Press Releases
Trevi Therapeutics Announces License Agreements for use of Nalbuphine for the Treatment of Levodopa-Induced Dyskinesia (LID) in Parkinson’s Disease
Agreements with Rutgers and MentiNova for exclusive worldwide rights to issued U.S. patents and pending patent applications
Trevi plans Phase 2 trial of nalbuphine ER for LID in patients with Parkinson’s disease in 2019
New Haven, CT, February 4, 2019 – Trevi Therapeutics, Inc. (“Trevi”), a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions, today announced that it had entered into exclusive license agreements with Rutgers, The State University of New Jersey and MentiNova, Inc. for intellectual property and data supporting the development of nalbuphine ER for levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease.
MentiNova was co-founded by Dr. M. Maral Mouradian, a movement disorders specialist and Endowed Chair for Parkinson’s Research at Rutgers University. In preclinical research in a non-human primate model of Parkinson’s disease, treatment with nalbuphine resulted in a statistically significant reduction in dyskinesia, maintaining anti-LID activity with chronic administration, and was safe and well tolerated.
“We believe that several serious neurologically mediated conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous system. We have been developing nalbuphine ER for chronic pruritic conditions and believe it also has the potential to be effective in LID, as supported by MentiNova’s preclinical data. We look forward to advancing nalbuphine ER into a Phase 2 trial in Parkinson’s patients with LID in 2019,” said Jennifer L. Good, Trevi’s President & CEO.
Dr. Mouradian, President of MentiNova, said “I am pleased to see our preclinical work advance with Trevi as they move this program directly into patients with Parkinson’s disease. We have studied the mechanism of action of nalbuphine and believe it has the potential to provide a much-needed therapeutic option for patients suffering from levodopa-induced dyskinesia.”
Under the terms of the agreements, Trevi has an exclusive license to two issued U.S. patents, one issued Japanese patent, and additional pending applications in the U.S., Canada and Europe, as well as associated know-how. These patents relate to the use of nalbuphine in various movement disorders, including LID.
About Levodopa-Induced Dyskinesia in Parkinson’s Disease
In the United States, there are close to one million people living with Parkinson’s disease, a chronic neurodegenerative disorder that primarily affects motor function, with an estimated 150,000 people having levodopa-induced dyskinesia. Levodopa, which replaces depleted dopamine in this condition, is considered the “gold standard” and the most effective therapy for Parkinson’s disease. Over time, however, people with Parkinson’s disease require increasingly higher or more frequent doses of levodopa to avoid recurrent periods when levodopa is ineffective. These periods are characterized by the return of the underlying symptoms of Parkinson’s disease including slowness of movement, rigidity, impaired walking, tremors, and postural instability. Long-term treatment of Parkinson’s disease with levodopa also frequently results in dyskinesia, which is characterized by involuntary movements that are non-rhythmic, purposeless and unpredictable, impacting peoples’ daily lives. Approximately 62% of the estimated one million Parkinson’s disease patients in the United States are treated with levodopa, and as the disease advances, approximately 50% of patients on levodopa therapy experience debilitating dyskinesia after 5 years and 90% do so after 15 years of levodopa therapy.
About Nalbuphine ER
Nalbuphine ER is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine’s mechanism of action also mitigates the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States or Europe.
About Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey, is a leading national research university and the state of New Jersey’s preeminent, comprehensive public institution of higher education. Established in 1766, the university is the eighth oldest higher education institution in the United States. More than 70,000 students and 23,400 full- and part-time faculty and staff learn, work, and serve the public at Rutgers locations across New Jersey and around the world.
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions. Trevi is currently developing nalbuphine ER for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Trevi is currently conducting a pivotal Phase 2b/3 clinical trial of nalbuphine ER, referred to as the PRISM trial, in patients with severe pruritus associated with prurigo nodularis.
Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT. For additional information, visit www.trevitherapeutics.com.
Trevi Therapeutics Appoints Anne M. VanLent to Board of Directors
Brings over 30 years of experience working with emerging growth life sciences companies
New Haven, Conn., October 10, 2018 – Trevi Therapeutics, Inc. (“Trevi”), a late-stage biopharmaceutical company focused on developing Nalbuphine ER for chronic pruritus and other serious neurological conditions, today announced the appointment of Anne M. VanLent to Trevi’s Board of Directors, effective immediately. Ms. VanLent will serve as Chair of the Audit Committee.
Ms. VanLent joins Trevi’s Board with over 30 years of experience working with emerging growth life sciences companies. She founded and serves as President of AMV Advisors, an advisory firm that provides strategic and management consulting services to emerging growth companies in the life sciences industry. Ms. VanLent has held senior executive and financial leadership roles with Barrier Therapeutics, Inc., Sarnoff Corporation (a division of SRI International), Trophix Pharmaceuticals, Inc. and The Liposome Company, Inc. She is currently a member of the board of directors and audit chair of both Vaxart, Inc. and Advanced Genetic Technologies, Inc. and has held prior board seats for Ocera, Novelion, Onconova, Integra Life Sciences, Penwest Pharmaceuticals, and several private companies. Ms. VanLent received a B.A. in Physics from Mount Holyoke College.
“Anne brings extensive strategic and financial experience in management and board governance of life sciences companies. Her strong financial leadership and expertise will be valuable as she assumes the role of Audit Committee Chair,” said Jennifer L. Good, President and Chief Executive Officer.
“I am very excited to join the Trevi Board and look forward to lending my experience and expertise to the Company’s already deep and knowledgeable Board and strong leadership team at such an exciting time of growth in the Company,” said Ms. VanLent.
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a late-stage biopharmaceutical company focused on developing Nalbuphine ER for chronic pruritus and other serious neurological conditions. Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing several pruritic conditions for clinical development, including its lead indication of prurigo nodularis. Prurigo nodularis is a chronic pruritic dermatologic condition characterized by the presence of pruriginous lesions on the skin and major alteration on the quality of life of the patients. There are no approved therapies in the U.S. or EU for this condition. Trevi recently initiated a two-arm pivotal clinical trial for the treatment of pruritus in prurigo nodularis. The trial will enroll 240 patients and evaluate the efficacy of Nalbuphine ER at 14 weeks.
About Nalbuphine ER
Nalbuphine ER is an oral extended release formulation of nalbuphine that is both a mixed mu receptor antagonist and a kappa receptor agonist. Each of these mechanisms of action has been shown in research to be effective in abolishing itch, and the neurobiology of these mechanisms of action indicates that these mechanisms have a dynamic and synergistic relationship. Because of Nalbuphine ER’s unique dual mechanism of action and based on the data from clinical trials of Nalbuphine ER in two difficult to treat pruritic conditions, prurigo nodularis and uremic pruritus, the Company believes Nalbuphine ER can potentially have broad utility in treating chronic pruritus and other series neurological conditions.
Founded in 2011, Trevi Therapeutics is headquartered in New Haven, Conn. For additional information, visit www.trevitherapeutics.com.
Trevi Therapeutics Initiates Pivotal Clinical Trial of Nalbuphine ER for the Treatment of Pruritus in Prurigo Nodularis
Pruritus Relief thru Itch-Scratch Modulation (PRISM) Trial to enroll 240 patients and evaluate efficacy of Nalbuphine ER at 14 weeks
New Haven, CT, September 27, 2018 – Trevi Therapeutics, Inc. (“Trevi”), a late-stage biopharmaceutical company focused on developing Nalbuphine ER for chronic pruritic and other serious neurological conditions, today announced initiation of a pivotal clinical trial evaluating Nalbuphine ER in patients with pruritus in prurigo nodularis (PN). PN is a severely pruritic dermatological condition characterized by nodules and papules with excoriations and ulcerations for which there are no approved therapies. The PRISM trial is a randomized, double-blind, placebo-controlled, two-arm study, with an open label extension period following double blind treatment. The study will enroll 240 eligible patients that will be randomized 1:1 to receive either oral Nalbuphine ER 162 mg twice daily or placebo.
“PRISM represents the most robust clinical trial conducted in PN to date, with 240 patients being studied over 14 weeks, and the opportunity for patients to continue into a one year open-label extension study. We believe studying the long-term safety as well as the nodule and excoriation healing of the skin is very important in this disease and in establishing the value of Nalbuphine ER,” said Jennifer L. Good, President and Chief Executive Officer.
“We are excited to initiate this robust pivotal trial following the positive results achieved in our Phase 2 trial of Nalbuphine ER which reduced itch intensity in PN, together with improving other supportive efficacy endpoints in PN. We are now enrolling patients in the US and plan to open sites in Europe by the end of 2018,” said Dr. Helena Brett-Smith, Chief Development Officer.
PRISM Pivotal Trial Design
The PRISM trial is a randomized, double-blind, placebo-controlled, parallel, two-arm 14 week treatment study that will evaluate the safety and anti-pruritic efficacy of Nalbuphine ER 162 mg tablets in 240 PN patients with severe pruritus from PN in approximately 40 centers in the US and Europe.
The primary efficacy endpoint for the study is the proportion of patients achieving at least a 4-point improvement from baseline with respect to their worst itch at week 14 as measured by the Numerical Rating Scale. The study also includes several other secondary endpoints, including quality of life measurements and skin healing.
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a late-stage biopharmaceutical company focused on developing Nalbuphine ER for chronic pruritic and other serious neurological conditions. Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing several pruritic conditions for clinical development, including its lead indication of prurigo nodularis. Prurigo nodularis is a chronic pruritic dermatologic condition characterized by the presence of pruriginous lesions on the skin and major alteration on the quality of life of the patients. There are no approved therapies in the U.S. or EU for this condition.
Nalbuphine ER is a unique oral extended release mixed mu receptor antagonist and kappa receptor agonist, both of which have been shown in research to be effective in abolishing itch, and which the neurobiology indicates has a dynamic and synergistic relationship. Because of Nalbuphine ER’s unique dual mechanism of action, which has shown efficacy in two difficult to treat pruritus conditions of prurigo nodularis and uremic pruritus, the Company believes Nalbuphine ER can potentially have broad utility in treating chronic pruritus.
Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT. For additional information, visit www.trevitherapeutics.com.
Trevi Therapeutics Appoints Yann Mazabraud as Chief Commercial Officer and Head of International
New Haven, CT, July 19, 2018 – Trevi Therapeutics, Inc. (“Trevi”), a late-stage biopharmaceutical company focused on developing Nalbuphine ER for chronic pruritic conditions, announced today that it has named Yann Mazabraud as its Chief Commercial Officer and Head of International. Mr. Mazabraud will join Trevi’s senior management team and be responsible for overseeing Trevi’s commercial strategy and international operations.
“I am excited to welcome Yann to our executive leadership team,” said Jennifer L. Good, President and Chief Executive Officer of Trevi. “Trevi is advancing its lead indication into pivotal trials and expanding its pipeline into new indications where we believe Nalbuphine ER’s unique mechanism of action could be effective. Yann’s extensive experience in commercial strategy, marketing and market access in the U.S., Europe and Latin America will prove to be valuable at this important time of growth for the Company.”
With over two decades of commercial and general management experience in the biopharmaceutical industry, Mr. Mazabraud joins Trevi from an extensive career at Sanofi Genzyme where he most recently served as U.S. General Manager and North America Head, Rare Diseases. Mr. Mazabraud has held multiple leadership positions while at Sanofi Genzyme including Vice President and Head of Latin America. In his most recent roles, he reported to the CEO and was a member of the Sanofi Genzyme Executive Leadership Team. Mr. Mazabraud holds a Masters in Management from Ecole Supérieure de Commerce de La Rochelle.
“Trevi has a unique therapeutic platform with the potential to bring new and transformative therapies to patients affected by severe diseases with currently no options,” said Mr. Mazabraud. “I’m thrilled to join a passionate team that is working relentlessly for the benefit of thousands of patients worldwide, and I look forward to contributing to Trevi’s future growth and continued success.”
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a late-stage biopharmaceutical company focused on developing Nalbuphine ER for chronic pruritic conditions. Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing several pruritic conditions for clinical development, including its lead indication of prurigo nodularis. Prurigo nodularis is a chronic pruritic dermatologic condition characterized by the presence of pruriginous lesions on the skin and major alteration on the quality of life of the patients. There are no approved therapies in the US or EU for this condition.
Nalbuphine ER is an oral extended release synthetic opioid with a dual mechanism of action, mu receptor antagonist and kappa receptor agonist, both of which have been shown in research to be effective in abolishing itch. Because of Nalbuphine ER’s unique dual mechanism of action, which has shown efficacy in addressing pruritus in human clinical trials, the Company believes Nalbuphine ER can have broad utility in treating chronic pruritus.
Founded in 2011, Trevi is headquartered in New Haven, CT. For additional information, visit www.trevitherapeutics.com.
Trevi Therapeutics to Present at UBS Global Healthcare Conference
New Haven, CT, May 17, 2018 – Trevi Therapeutics, Inc. (“Trevi”), a late-stage biopharmaceutical company focused on developing Nalbuphine ER for chronic pruritic conditions, today announced that Jennifer Good, President and Chief Executive Officer, will present at the UBS Global Healthcare Conference. The presentation will take place at the Grand Hyatt in New York City on Monday, May 21 at 3:00 pm ET.
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a late-stage biopharmaceutical company focused on developing Nalbuphine ER for chronic pruritic conditions. Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing several pruritic conditions for clinical development, including its lead indication of prurigo nodularis. Prurigo nodularis is a chronic pruritic dermatologic condition characterized by the presence of pruriginous lesions (excoriative/ulcerative papules and nodules) on the skin. There are no approved therapies in the US or EU for this condition.
Nalbuphine ER is an oral extended release synthetic opioid with a dual mechanism of action, mu receptor antagonist and kappa receptor agonist, both of which have been shown in research to be effective in abolishing itch. Because of Nalbuphine ER’s unique dual mechanism of action, which has shown efficacy in addressing pruritus in human clinical trials, the Company believes Nalbuphine ER can have broad utility in treating chronic pruritus.
Founded in 2011, Trevi is headquartered in New Haven, CT. For additional information, visit www.trevitherapeutics.com.
Trevi Therapeutics Appoints Christopher J. Seiter as Chief Financial Officer
New Haven, CT, March 15, 2018 – Trevi Therapeutics, Inc. (“Trevi”), a late-stage clinical development company focused on developing Nalbuphine ER for chronic pruritus (itch), today announced that Jennifer Good, President and Chief Executive Officer, will present at Needham & Company’s 17th Annual Healthcare Conference. The presentation will take place in New York City on Tuesday, March 27 at 4:30 pm ET.
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a late-stage clinical development company focused on developing Nalbuphine ER for chronic pruritus (itch). Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing several pruritic conditions for clinical development, including its lead indication of prurigo nodularis. Prurigo nodularis is a chronic pruritic dermatologic condition characterized by the presence of pruriginous lesions (excoriative/ulcerative papules and nodules) on the skin. There are no approved therapies in the US or EU for this condition.
Nalbuphine ER is an oral extended release synthetic opioid with a dual mechanism of action, mu receptor antagonist and kappa receptor agonist, both of which have been shown in research to be effective in abolishing itch. Because of Nalbuphine ER’s unique dual mechanism of action, which has shown efficacy in addressing pruritus in both animal studies and human clinical trials, the Company believes Nalbuphine ER can have broad utility in treating chronic pruritus.
Founded in 2011, Trevi is headquartered in New Haven, CT. For additional information, visit www.trevitherapeutics.com.
Trevi Therapeutics to Present at Needham & Company’s 17th Annual Healthcare Conference
New Haven, CT, March 21, 2018 – Trevi Therapeutics, Inc. (“Trevi”), a late-stage clinical development company focused on developing Nalbuphine ER for chronic pruritus (itch), today announced that Jennifer Good, President and Chief Executive Officer, will present at Needham & Company’s 17th Annual Healthcare Conference. The presentation will take place in New York City on Tuesday, March 27 at 4:30 pm ET.
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a late-stage clinical development company focused on developing Nalbuphine ER for chronic pruritus (itch). Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing several pruritic conditions for clinical development, including its lead indication of prurigo nodularis. Prurigo nodularis is a chronic pruritic dermatologic condition characterized by the presence of pruriginous lesions (excoriative/ulcerative papules and nodules) on the skin. There are no approved therapies in the US or EU for this condition.
Nalbuphine ER is an oral extended release synthetic opioid with a dual mechanism of action, mu receptor antagonist and kappa receptor agonist, both of which have been shown in research to be effective in abolishing itch. Because of Nalbuphine ER’s unique dual mechanism of action, which has shown efficacy in addressing pruritus in both animal studies and human clinical trials, the Company believes Nalbuphine ER can have broad utility in treating chronic pruritus.
Founded in 2011, Trevi is headquartered in New Haven, CT. For additional information, visit www.trevitherapeutics.com.
Trevi Therapeutics Hires Dr. Helena Brett-Smith as Chief Development Officer
Highly experienced clinical drug developer to oversee R&D functions and Companys Phase 3 development program
New Haven, CT, October 12, 2017 – Trevi Therapeutics, Inc. (“Trevi” or the “Company”), a late-stage clinical development company focused on developing Nalbuphine ER ffor chronic pruritus (itch), today announced that it has hired Helena Brett-Smith, M.D., as Chief Development Officer.
Dr. Brett-Smith has more than 25 years of clinical and drug development experience. She comes to Trevi from a 17-year career at Bristol-Myers Squibb, where she was most recently Vice President and Head of Fibrosis Full Development. Dr. Brett-Smith has held leadership positions for multiple investigational agents in clinical-stage development. These projects included both small molecules and biologics, and spanned varied therapeutic areas including Virology (HIV, Hepatitis B and Hepatitis C), Immuno-Oncology and Fibrosis. Dr. Brett-Smith has extensive experience with successful regulatory filings for new therapies in both the US and Europe, and with follow-on pediatric indications. She led the global lifecycle development program for BARACLUDE® and has substantial Asian experience, including China, Japan and Korea.
Dr. Brett-Smith earned her undergraduate degree from Yale University and her MD from Stanford University School of Medicine. She completed both a residency in Internal Medicine and a fellowship in Infectious Diseases at the Yale School of Medicine. Prior to joining Bristol-Myers Squibb, she was Director of the HIV Program and Haelen Center at the Hospital of Saint Raphael in New Haven, CT from 1992 to 2000.
Jennifer Good, Trevi’s President and Chief Executive Officer, said, “We are very pleased to add Dr. Brett-Smith’s strong development and regulatory experience to the Trevi team as we continue the development of Nalbuphine ER for chronic pruritus conditions into Phase 3 studies.”
Dr. Brett-Smith added, “I am excited about the significant unmet medical need in pruritus. It is a particular pleasure to join Dr. Sciascia and the strong development team at Trevi, and I look forward to advancing Nalbuphine ER across various itch indications.”
Trevi recently completed a Series C financing of $50.8 million led be New Enterprise Associates, using the proceeds to advance the development of Nalbuphine ER, a drug with a dual agonist/antagonist mechanism of action uniquely suited to treating itch associated in various dermatologic, metabolic, hematologic, and neuropathic conditions, and also announced positive Phase 2 trial results in reduced itch intensity and other supporting efficacy endpoints in patients with prurigo nodularis, as well as a statistically significant reduction in itch intensity in a Phase 2/3 trial in uremic pruritus.
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a late-stage clinical development company focused on developing Nalbuphine ER for chronic pruritus (itch). Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing two conditions for clinical development: prurigo nodularis and uremic pruritus. Prurigo nodularis is a chronic pruritic dermatologic condition characterized by the presence of pruriginous lesions (excoriative/ulcerative papules and nodules) on the skin. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with increased mortality. There are no approved therapies in the US or EU for either condition.
Nalbuphine ER is an oral extended release synthetic opioid with a dual mechanism of action, mu receptor antagonist and kappa receptor agonist, both of which have been shown in research to be effective in abolishing itch. Because of Nalbuphine ER’s unique dual mechanism of action, which has shown efficacy in addressing pruritus in both animal studies and human clinical trials, the Company believes Nalbuphine ER can have broad utility in treating chronic pruritus.
Founded in 2011, Trevi is headquartered in New Haven, CT.
For additional information, visit www.trevitherapeutics.com.
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Media contact: Laura Brophy, (203) 331-7618, lbrophy@marketcompr.com
Trevi Therapeutics Raises $50 Million Series C Financing Led by New Enterprise Associates
Company continuing the development of Nalbuphine ER in chronic pruritus conditions
New Haven, CT, July 20, 2017 – Trevi Therapeutics, Inc. (“Trevi” or the “Company”), announced today that the Company has completed a Series C financing of $50.5 million led by New Enterprise Associates (NEA). The financing round included new investors Lundbeckfonden Ventures, Omega Funds and Aperture Venture Partners, along with the Company’s largest existing investor, TPG Biotech. The Company plans to use the proceeds from the financing to advance the development of Nalbuphine ER, a drug with a dual agonist/antagonist mechanism of action uniquely suited to treating itch associated in various dermatologic, metabolic, hematologic, and neuropathic conditions.
Trevi previously announced positive Phase 2 trial results in reduced itch intensity and other supporting efficacy endpoints in patients with prurigo nodularis, as well as a statistically significant reduction in itch intensity in a Phase 2/3 trial in uremic pruritus. The Company also conducted a six-month open label extension study in uremic pruritus, in which Nalbuphine ER was well tolerated and showed a durability of drug effect on efficacy, and recently completed a one-year open label extension trial conducted in prurigo nodularis.
Jennifer Good, Trevi’s President and Chief Executive Officer, said, “We are encouraged by our robust data, which includes, the positive blinded Phase 2 results which we previously announced in both prurigo nodularis and uremic pruritus. The Company also recently completed a one-year open label trial in prurigo nodularis in which Nalbuphine ER was well tolerated and all patients who completed dosing showed evidence of lesion healing. We are very pleased to welcome this experienced syndicate of investors as we advance the development of Nalbuphine ER into pivotal studies.”
Ed Mathers, Partner, of NEA said, “Chronic, severe pruritus is a significant unmet medical need in which there is significant strategic interest. We look forward to working with the Trevi team to further the development of Nalbuphine ER as it completes its Phase 3 development program.”
In connection with the financing, David Meeker, MD, former CEO of Sanofi/Genzyme, will join Trevi’s Board of Directors as Chairman. In addition, Ed Mathers of NEA, Mette Kirstine Agger of Lundbeckfond, and Otello Stampacchia, PhD of Omega Funds will also join the Board. Other members of the Board include Eran Nadav, PhD of TPG Biotech, Jennifer Good, CEO of Trevi, Michael Heffernan, CEO of Collegium, and Cayce Denton.
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a late-stage clinical development company focused on developing Nalbuphine ER for chronic pruritus (itch). Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing two conditions for clinical development: prurigo nodularis and uremic pruritus. Prurigo nodularis is a chronic pruritic dermatologic condition characterized by the presence of pruriginous lesions (excoriative/ulcerative papules and nodules) on the skin. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with increased mortality. There are no approved therapies in the US or EU for either condition.
Nalbuphine ER is an oral extended release synthetic opioid with a dual mechanism of action, mu receptor antagonist and kappa receptor agonist, both of which have been shown in research to be effective in abolishing itch. Because of Nalbuphine ER’s unique dual mechanism of action, which has shown efficacy in addressing pruritus in both animal studies and human clinical trials, the Company believes Nalbuphine ER can have broad utility in treating chronic pruritus.
Founded in 2011, Trevi is headquartered in New Haven, CT.
For additional information, visit www.trevitherapeutics.com.
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Media contact: Laura Brophy, (203) 331-7618, lbrophy@marketcompr.com
Trevi Therapeutics Names Michael Heffernan to its Board of Directors
Senior pharma executive brings clinical development and commercial background as the Company moves into Phase 3 trials for Nalbuphine ER in chronic pruritus conditions
New Haven, CT, July 20, 2017 – Trevi Therapeutics, Inc. (“Trevi”), a late-stage therapeutics company developing Nalbuphine ER for chronic pruritus conditions, announced today that it has named Michael Heffernan to its Board of Directors.
As Founder, President and CEO of Collegium Pharmaceutical, Inc., Mr. Heffernan comes to Trevi’s Board of Directors with over 25 years of strong executive, clinical development and commercial experience within the pharmaceutical and healthcare industries. He was previously the Founder, President and CEO of Onset Dermatologics, a dermatology-focused company that was spun out of Collegium to create PreCision Dermatology and was later sold to Valeant. Earlier, he was Co-Founder, President and CEO of Clinical Studies Ltd., a pharmaceutical contract research organization that was sold to PhyMatrix Corp, and later served as President and CEO of PhyMatrix. Mr. Heffernan began his career at Eli Lilly and Company. He is currently the Chairman of Veloxis Pharmaceuticals A/S (OMX: VELO) and serves on the board of Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX).
Trevi’s Chairman, Eran Nadav, PhD, said, “Trevi is pleased to be adding another well-respected pharmaceutical executive to the Board. Mike’s extensive background in dermatology and pain is a great fit with Trevi’s therapeutic areas of focus and will be valuable as we move into Phase 3 development of Nalbuphine ER in moderate to severe chronic pruritus conditions.”
In addition to Dr. Nadav, Trevi’s Board currently includes Jennifer L. Good, Trevi’s co-founder, President and CEO; W. James O’Shea; and Cayce Denton. Dr. David Meeker is also an Advisor to the Board.
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a late-stage clinical development company focused on developing Nalbuphine ER for chronic pruritus (itch). Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing two conditions for clinical development: prurigo nodularis and uremic pruritus. Prurigo nodularis is a chronic pruritic dermatologic condition characterized by the presence of nodules on the skin. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with increased mortality. There are no approved therapies in the US or EU for either condition.
Nalbuphine ER is an oral extended release opioid with a dual mechanism of action, mu receptor antagonist and kappa receptor agonist, both of which have been shown in research to be effective in abolishing itch. Because of Nalbuphine ER’s unique dual mechanism of action, which has shown efficacy in addressing pruritus in both animal studies and human clinical trials, the Company believes it can have broad utility in treating chronic pruritus.
Founded in 2011, Trevi is headquartered in New Haven, CT.
For additional information, visit www.trevitherapeutics.com
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Trevi Therapeutics Selected to Present at the American Society of Nephrology’s Kidney Week 2016 Phase 2/3 Data for NalbuphineER in Uremic Pruritus
Presentation Abstract: Time Course of Reduction in Itch Intensity During and Following Treatment with Nalbuphine ER Tablets: A Randomized, Placebo-Controlled Trial in Patients with Uremic Pruritus
New Haven, CT, November 16, 2016 – Trevi Therapeutics, Inc. (“Trevi”), a late-stage clinical development company developing Nalbuphine ER for chronic pruritus conditions, will make an oral abstract presentation on their Phase 2/3 clinical trial of Nalbuphine HCI ER tablets at the American Society of Nephrology’s Kidney Week 2016, in Chicago, IL on November 18th at 6:06 pm CST during the Patient-Centered Outcomes with Maintenance Dialysis Oral Abstract Session in Room W185.
The presentation FR-OR083: “Time Course of Reduction in Itch Intensity During and Following Treatment with Nalbuphine ER Tablets: A Randomized, Placebo-Controlled Trial in Patients with Uremic Pruritus” will be presented by Dr. Thomas Sciascia, the Company’s Chief Medical Officer.
Thomas Sciascia, MD, Trevi’s co-founder and Chief Medical Officer, said, “Uremic pruritus is a debilitating chronic condition which significantly affects quality of life. Despite the fact that 60% of dialysis patients suffer from pruritus, there are currently no approved treatments in the US or Europe. We were very pleased with the statistically significant outcome of reduction in itch intensity with Nalbuphine ER in this trial, as well as the other important findings in the study results that are clinically relevant to the serious medical condition of uremic pruritus”
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a late-stage clinical development company focused on developing Nalbuphine ER for chronic pruritus (itch). Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing two conditions for clinical development: uremic pruritus and prurigo nodularis. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with increased mortality. Prurigo nodularis is a chronic pruritic dermatologic condition characterized by the presence of nodules on the skin. There are no approved therapies in the U.S. or EU for either condition. The Company has completed Phase 2 trials in both of these conditions and has reported positive data.
Nalbuphine ER is an oral extended release opioid with a dual mechanism of action, mu receptor antagonist and kappa receptor agonist, both of which have been shown in research to be effective in abolishing itch. Because of Nalbuphine ER’s unique dual mechanism of action, which has shown efficacy in addressing pruritus in both animal studies and human clinical trials, the Company believes it can have broad utility in treating chronic pruritus.
Founded in 2011, Trevi is headquartered in New Haven, CT.
For additional information, visit www.trevitherapeutics.com.
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Trevi Therapeutics Announces Positive Results from Phase 2 Trial in Prurigo Nodularis
Oral Nalbuphine ER trial achieved positive results of reduced itch intensity and other supporting efficacy endpoints in prurigo nodularis patients
New Haven, CT, October 13, 2016 – Trevi Therapeutics, Inc. (“Trevi” or the “Company”), a late-stage clinical development company developing oral Nalbuphine ER for chronic pruritus conditions, today announced positive results from its Phase 2 trial for the treatment of moderate to severe prurigo nodularis. Prurigo nodularis (PN), a severely pruritic dermatological condition characterized by itchy skin papules and nodules, has significant impact on quality of life and has no approved therapies. Trevi also previously reported statistically significant results from a robust Phase 2/3 trial with Nalbuphine ER in hemodialysis patients with uremic pruritus.
The multi-center, randomized, double-blind, placebo-controlled, parallel, three-arm study evaluated the safety and anti-pruritic efficacy of Nalbuphine ER tablets dosed twice-daily at 90mg and 180mg in 62 patients in the United States and Europe. Patients with moderate-to-severe itch intensity, defined as ≥ 5 on the 0-10 Numerical Rating Score (NRS) scale, were enrolled to evaluate drug efficacy across a representative patient population for treatment of this chronic indication. The actual average baseline worst itch for enrolled patients was ≥ 8, indicating the severe nature of the disease.
The study consisted of a titration period of two weeks, followed by an eight-week blinded period on a fixed dose of drug or placebo, and a two-week wash-out period. At the end of the wash-out period, patients were eligible to roll over into a one-year open label extension study. The Company expects the open label extension study to be completed in the third quarter of 2017.
The main outcome variables for this study were responder analyses of the proportion of patients with at least a 30% or 50% reduction in their 7-day worst-itch intensity NRS from baseline to completion of treatment at week 10 or last observation visit. The proportion of patients in the Nalbuphine ER 180 mg BID arm meeting 50% responder criteria at week 10 or last observed visit (MITT population with n=18) approached statistical significance (p=0.083), and this arm met statistical significance for patients (n=12) completing treatment (p=0.028). The mean change in worst itch NRS was additionally evaluated, and the MITT population of the Nalbuphine ER 180 mg BID arm as compared to placebo approached statistical significance (p=0.083) as well. This arm also met statistical significance for patients (n=12) completing treatment (p=0.025).
The ItchyQoL™ secondary endpoint, 22 questions that measure how pruritus affects a patient’s quality of life, provided supportive evidence of a favorable treatment effect on reduction in itch intensity compared to placebo. Change from baseline in the ItchyQoL total score was significantly more favorable for the Nalbuphine ER 180 mg BID dose compared to placebo (p=0.022).
The most common adverse events in the study were dizziness, nausea, headaches, and fatigue, the majority of which were grade 1 or 2. As seen previously, the incidence rate of these events was similar to placebo after the titration period. No serious adverse events attributed to the drug were observed, and the study DSMB raised no issues that affected the continuation of the study or required modification of study procedures.
Jennifer L. Good, Trevi’s President and Chief Executive Officer, said, “We have now demonstrated that Nalbuphine ER can improve pruritus in two very different and severe itch conditions: prurigo nodularis and uremic pruritus. Itch is a significant unmet medical need resulting from many diseases in dermatology, oncology, hepatology and neurology, and we believe Nalbuphine ER may provide an important therapy for these patients.”
Thomas R. Sciascia, M.D., Trevi’s Chief Medical Officer, said, “Prurigo nodularis is a very serious dermatologic condition, with no approved therapies. Once a patient gets PN, they may cope with the disease for many years, with significant impact on their ongoing quality of life. We are pleased with the results of our trial, and are preparing for a discussion with both FDA and EMA about the development path forward with the critical mass of data we have gathered.”
Trevi is preparing for an end of Phase 2 meeting for prurigo nodularis, has already held an end of Phase 2 meeting with FDA for uremic pruritus, and will initiate Phase 3 trials in both conditions in 2017.
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a late-stage clinical development company developing oral Nalbuphine ER for chronic pruritus conditions (itch). Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing two conditions for clinical development: uremic pruritus and prurigo nodularis. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with increased mortality. Prurigo nodularis is a chronic dermatologic condition characterized by severely pruritic skin nodules that are independent of underlying etiology. There are no approved therapies in the United States or Europe for either condition.
Nalbuphine ER is an oral extended release mu receptor antagonist and kappa receptor agonist. Both modalities have been shown to be effective in abolishing itch. Trevi believes that Nalbuphine ER’s unique dual mechanism of action, which has shown efficacy in addressing pruritus in both animal studies and human clinical trials, may have broad utility in treating chronic pruritus.
Founded in 2011, Trevi is headquartered in New Haven, CT.
For additional information, visit www.trevitherapeutics.com.
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Trevi Therapeutics Announces Completion of Enrollment in Phase 2/3 Study of Nalbuphine ER in Prurigo Nodularis
Company expects to report data in Q3 2016
New Haven, CT, June 2, 2016 – Trevi Therapeutics, Inc. (“Trevi” or the “Company”), a late stage clinical development company developing Nalbuphine ER for chronic pruritus conditions, today announced the completion of enrollment in a pivotal study of Nalbuphine ER in patients with prurigo nodularis. Prurigo nodularis (PN) is a severely pruritic dermatological condition characterized by itchy skin papules and nodules, and has no approved therapies. In its most recent data release in Q4 2015, Trevi reported positive results from another pivotal trial with Nalbuphine ER in hemodialysis patients with uremic pruritus.
The multi-center, randomized, double-blind, placebo-controlled, parallel, three-arm study will evaluate the safety and anti-pruritic efficacy of Nalbuphine ER tablets in 63 prurigo nodularis patients in the US and Europe. The primary endpoint for the study is a reduction in itch intensity as measured by the Numerical Rating Scale in patients with moderate to severe pruritus from PN. The study also includes several other secondary endpoints, including patient perception of the burden of itch, quality of life effects of pruritus, and impact on sleep and mood.
The study consists of a titration period of two weeks, followed by an eight-week blinded period on a fixed dose of the drug or placebo and a wash-out period. At the end of the wash-out period, patients are eligible to roll-over into a one-year open label extension study which will help generate data on the safety and duration of the effects of the drug and whether prolonged reduction in itching results in the healing of the skin lesions characteristic of prurigo nodularis.
Jennifer L. Good, Trevi’s President and Chief Executive Officer, said, “We are very pleased about the completion of the enrollment for this trial in a population with great unmet need. We look forward to reporting the final data in the third quarter of 2016 and being able to bring this first ever treatment forward for patients.”
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a late-stage clinical development company focused on developing Nalbuphine ER for chronic pruritus (itch). Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing two conditions for clinical development: uremic pruritus and prurigo nodularis. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with increased mortality. Prurigo nodularis is a chronic dermatologic condition characterized by severely pruritic nodules on the skin that are independent of underlying etiology. There are no approved therapies in the US or EU for either condition.
Nalbuphine ER is an oral extended release opioid with a unique opioid receptor dual agonist/antagonist mechanism of action, which has shown efficacy in addressing pruritus in both animal studies and human clinical trials. Because of Nalbuphine ER’s dual mechanism of action, the company believes it can have broad utility in treating chronic pruritus.
Founded in 2011, Trevi is headquartered in New Haven, CT.
For additional information, visit www.trevitherapeutics.com.
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Trevi Therapeutics to Present Two Posters at the National Kidney Foundation Spring 2016 Meeting
Authors available to discuss clinical studies results regarding Nalbuphine ER for hemodialysis patients with uremic pruritus
New Haven, CT, April 28, 2016 – Trevi Therapeutics, Inc. (“Trevi”), a late-stage clinical development company developing Nalbuphine ER for chronic pruritus conditions, will present two posters at the National Kidney Foundation Spring 2016 Meeting in Boston, MA on April 28.
The two posters regarding Trevi’s uremic pruritus clinical trials are Nalbuphine ER Tablets in Hemodialysis Patients with Severe Uremic Pruritus: Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial, and Long-Term Effects of Nalbuphine ER Tablets in Hemodialysis Patients with Uremic Pruritus: A Multicenter Open-Label Trial.
Authors Vandana S. Mathur M.D., Paul W. Crawford, M.D., and Thomas Sciascia, M.D. will be available during the posters presentation from 6:00-7:30 PM.
“It is exciting to the see the growing interest in chronic pruritus at various medical meetings by both nephrologists and dermatologists,” said Thomas Sciascia, M.D. Trevi’s Chief Medical Officer. “This is the largest to date randomized trial in uremic pruritus and it demonstrated the efficacy of Nalbuphine ER for one of the most distressing complications of end stage renal disease, and in the most severe uremic pruritus population.”
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a late-stage clinical development company focused on developing Nalbuphine ER for chronic pruritus (itch). Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing two conditions for clinical development: uremic pruritus and prurigo nodularis. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with increased mortality. Prurigo nodularis is a chronic pruritic dermatologic condition characterized by the presence of nodules on the skin. There are no approved therapies in the U.S. or EU for either condition.
Nalbuphine ER is an oral extended release opioid with a dual mechanism of action, mu receptor antagonist and kappa receptor agonist, both of which have been shown in research to be effective in abolishing itch. Because of Nalbuphine ER’s unique dual mechanism of action, which has shown efficacy in addressing pruritus in both animal studies and human clinical trials, the Company believes it can have broad utility in treating chronic pruritus.
Founded in 2011, Trevi is headquartered in New Haven, CT.
For additional information, visit www.trevitherapeutics.com.
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Trevi Therapeutics’ Data to be Presented at the American Academy of Dermatology’s 74th Annual Meeting in Washington, DC
Presentation Abstract: Randomized, Double-Blind, Placebo-Controlled, Parallel, 3-Arm Study of Safety and Anti-Pruritic Efficacy of Nalbuphine HCl ER Tablets in Hemodialysis Patients with Uremic Pruritus
New Haven, CT, March 1, 2016 – Trevi Therapeutics, Inc. (“Trevi”), a late-stage clinical development company developing Nalbuphine ER for chronic pruritus conditions, will make an oral abstract presentation on the Company’s recent Phase 2/3 clinical trial of Nalbuphine HCI ER tablets at the 74th American Academy of Dermatology Annual Meeting in Washington, DC on Saturday, March 5, at 10:30 am, Eastern.
The presentation is based on Trevi’s recently completed uremic pruritus trial, submitted as Abstract 3723: “Randomized, Double-Blind, Placebo-Controlled, Parallel, 3-Arm Study of Safety and Anti-Pruritic Efficacy of Nalbuphine HCI ER Tablets in Hemodialysis Patients with Uremic Pruritus.” The data will be presented during the meeting’s Late-breaking Research Forums – Clinical Trials session by Dr. Jayant Kumar, a nephrologist and investigator in the trial.
Jayant Kumar, MD, the lead enrolling investigator in this trial, said, “Uremic pruritus is a debilitating chronic condition which significantly affects the quality of life of dialysis patients. Despite the fact that 60% of these patients suffer from pruritus, there are currently no approved treatments in the U.S. or Europe. We had strong patient interest in this trial, and look forward to further development work on this condition.”
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a late-stage clinical development company focused on developing Nalbuphine ER for chronic pruritus (itch). Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing two conditions for clinical development: uremic pruritus and prurigo nodularis. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with increased mortality. Prurigo nodularis is a chronic pruritic dermatologic condition characterized by the presence of nodules on the skin. There are no approved therapies in the U.S. or EU for either condition.
Nalbuphine ER is an oral extended release opioid with a dual mechanism of action, mu receptor antagonist and kappa receptor agonist, both of which have been shown in research to be effective in abolishing itch. Because of Nalbuphine ER’s unique dual mechanism of action, which has shown efficacy in addressing pruritus in both animal studies and human clinical trials, the Company believes it can have broad utility in treating chronic pruritus.
Founded in 2011, Trevi is headquartered in New Haven, CT.
For additional information, visit www.trevitherapeutics.com.
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Trevi Therapeutics Selected to Present at the American Society of Nephrologys Kidney Week 2015 at High-Impact Clinical Trials Session with Phase 2/3 Data for Nalbuphine ER
Presentation Abstract: Randomized, Double-Blind, Placebo-Controlled, Parallel, 3-Arm Study of Safety and Anti-Pruritic Efficacy of Nalbuphine HCI ER Tablets in Hemodialysis Patients with Uremic Pruritus
New Haven, CT, October 29, 2015 – Trevi Therapeutics, Inc. (“Trevi”), a late-stage clinical development company developing Nalbuphine ER for chronic pruritus conditions, will make an oral abstract presentation on their recent Phase 2/3 clinical trial of Nalbuphine HCI ER tablets at the American Society of Nephrology’s Kidney Week 2015, in San Diego, CA on November 7 at 12:00 pm PT in Hall D.
The presentation is based on Trevi’s late-breaking clinical trial, submitted as Abstract 6166: “Randomized, Double-Blind, Placebo-Controlled, Parallel, 3-Arm Study of Safety and Anti-Pruritic Efficacy of Nalbuphine HCI ER Tablets in Hemodialysis Patients with Uremic Pruritus,” and will be presented during the meeting’s High-Impact Clinical Trials session by Dr. Vandana Mathur, a nephrologist and key opinion leader in uremic pruritus.
Thomas Sciascia, MD, Trevi’s co-founder and Chief Medical Officer, said, “Uremic pruritus is a debilitating chronic condition which significantly affects quality of life. Despite the fact that 60% of dialysis patients suffer from pruritus, there are currently no approved treatments in the US or Europe. We were very pleased with the statistically significant results of Nalbuphine ER in this trial, and look forward to furthering the development of our drug in this condition.”
In other activity at Kidney Week 2015, Trevi will also exhibit Poster #TH-PO576 “A Multicenter, Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial of Nalbuphine ER Tablets for the Treatment of Uremic Pruritus: Baseline Population Characteristics.” The authors from the poster will be available on November 5, 2015 from 10:00 am PT to 12:00 pm PT to answer any questions.
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a late-stage clinical development company focused on developing Nalbuphine ER for chronic pruritus (itch). Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing two conditions for clinical development: uremic pruritus and prurigo nodularis. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with increased mortality. Prurigo nodularis is a chronic pruritic dermatologic condition characterized by the presence of nodules on the skin. There are no approved therapies in the U.S. or EU for either condition.
Nalbuphine ER is an oral extended release opioid with a dual mechanism of action, mu receptor antagonist and kappa receptor agonist, both of which have been shown in research to be effective in abolishing itch. Because of Nalbuphine ER’s unique dual mechanism of action, which has shown efficacy in addressing pruritus in both animal studies and human clinical trials, the Company believes it can have broad utility in treating chronic pruritus.
Founded in 2011, Trevi is headquartered in New Haven, CT.
For additional information, visit www.trevitherapeutics.com.
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Trevi Therapeutics Announces Positive Results from Phase 2/3 Trial in Uremic Pruritus
Oral Nalbuphine ER trial achieved statistically significant results on the primary endpoint of reducing itch intensity and also demonstrated sustained duration of effect
New Haven, CT, September 10, 2015 – Trevi Therapeutics, Inc. (“Trevi” or the “Company”), a late-stage clinical development company developing oral Nalbuphine ER for chronic pruritus conditions, today announced statistically significant results from its Phase 2/3 trial for the treatment of moderate to severe uremic pruritus. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with increased mortality, and currently has no approved therapies in the United States or Europe. Nalbuphine ER has a dual mechanism of action, as it is a mu receptor antagonist and kappa receptor agonist, and both mechanisms have been separately shown to be effective in abolishing itch.
The multi-center, randomized, double-blind, placebo-controlled, parallel, three-arm study evaluated the safety and anti-pruritic efficacy of Nalbuphine ER tablets dosed twice-daily at 60mg and 120mg in approximately 370 patients on hemodialysis in the United States and Europe. Patients with a wide range of mean moderate-to-severe itch intensity, ranging from 4.5 to 10 on the ten-point Numerical Rating Score (NRS) scale, were enrolled to evaluate efficacy across a representative patient population for this chronic indication.
The study consisted of a titration period of two weeks, followed by a six-week blinded period on a fixed dose of drug or placebo and a wash-out period. At the end of the wash-out period, patients were eligible to roll over into a six-month open label extension study. The Company expects the open label extension study to be completed by year-end.
Patients receiving 120 mg of Nalbuphine ER (n=120) experienced a 3.5 point reduction in itch intensity from baseline, resulting in a highly statistically significant mean reduction in itch intensity as compared to placebo (p-value = 0.017). A statistically significant mean reduction for Nalbuphine ER compared to placebo was observed as early as one week following titration to the Nalbuphine ER fixed dose, and there was a statistically significant separation from placebo throughout the remaining blinded period. Sustained duration of drug effect continued to trend away from placebo through the 8th week of the study. On average, patients entered the study with a baseline mean NRS itch score of 6.9 (just under severe NRS score of 7), and at the end of the 8 week dosing period, average itch scores had been reduced to an NRS score of 3.4, which is considered mild on the NRS scale. Severe itch patients (those with NRS scores greater than or equal to 7) experienced on average an NRS score reduction of 4.5 points from baseline, (p-value=0.007). The 60 mg dose showed a numerically favorable reduction over placebo, but did not achieve statistical significance.
The secondary endpoints, the Skindex-10 Disease Domain and the Itch MOS Sleep index, provided confirmatory evidence of a favorable Nalbuphine ER effect on itching compared to placebo.
Only one serious adverse event was attributed to the drug in the study, with the most common adverse events being nausea, vomiting, dizziness and somnolence. However, the rates of these events quickly resolved and were approaching placebo rates after the first week of titration. Because of the challenging nature of the patient population, the company elected to put in place a Data Safety Monitoring Board (“DSMB”) to oversee the safety of the study. The DSMB raised no issues that affected the continuation of the study.
Jennifer L. Good, Trevi’s President and Chief Executive Officer, said, “We are pleased with the results of this robust trial. We studied drug effect over eight weeks of dosing at sites in both the U.S. and Europe, and demonstrated statistically significant results on the primary, protocol-specified endpoint: reduction in worst itch severity as recorded by NRS score. We believe Nalbuphine ER may be useful broadly in itch conditions, and look forward to the results from our ongoing Phase 2/3 trial in prurigo nodularis, which will report out in the first half of next year. ”
Thomas R. Sciascia, M.D., Trevi’s Chief Medical Officer, said, “This is a difficult patient population to study over an extended period of time because of multiple co-morbidities. There was strong patient and physician interest in both the blinded portion of the study as well as the ongoing six-month open label extension trial. We look forward to a discussion with both the FDA and the European Medicines Agency about next steps in our program.”
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a late-stage clinical development company focused on developing Nalbuphine ER for chronic pruritus (itch). Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing two conditions for clinical development: uremic pruritus and prurigo nodularis. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with increased mortality. Prurigo nodularis is a chronic dermatologic condition characterized by severely pruritic nodules on the skin that are independent of underlying etiology. There are no approved therapies in the U.S. or EU for either condition.
Nalbuphine ER is an oral extended release opioid with a dual mechanism of action, mu receptor antagonist and kappa receptor agonist, both of which have been shown in research to be effective in abolishing itch. Because of Nalbuphine ER’s unique dual mechanism of action, which has shown efficacy in addressing pruritus in both animal studies and human clinical trials, the Company believes it can have broad utility in treating chronic pruritus.
Founded in 2011, Trevi is headquartered in New Haven, CT.
For additional information, visit www.trevitherapeutics.com.
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Trevi Therapeutics Announces Completion of Enrollment in Pivotal Study of Nalbuphine ER in Uremic Pruritus
Study enrolls four months ahead of schedule
New Haven, CT, March 31, 2015 – Trevi Therapeutics, Inc. (“Trevi” or the “Company”), a late-stage clinical development company developing Nalbuphine ER for chronic pruritus conditions, today announced the completion of enrollment in the pivotal study of Nalbuphine ER in hemodialysis patients with uremic pruritus. The Company commenced this trial in June 2014.
Jennifer L. Good, Trevi’s President and Chief Executive Officer, said, “We are very pleased that this trial has enrolled significantly ahead of schedule. We believe it speaks to the seriousness of moderate to severe uremic pruritus for patients on hemodialysis and the lack of good treatment options. We look forward to seeing the data and determining the next steps in being able to bring this treatment to patients.”
Thomas R. Sciascia, M.D., Trevi’s Chief Medical Officer, said, “The rate of enrollment in this trial confirms that there are a significant number of these patients with moderate to severe uremic pruritus, despite on-going hemodialysis. In addition, we have seen a strong rollover rate of these patients into our six month open label extension trial. We look forward to following their progress.”
The multi-center, randomized, double-blind, placebo-controlled, parallel, three-arm study evaluates the safety and anti-pruritic efficacy of Nalbuphine ER tablets dosed twice-daily in approximately 360 hemodialysis patients in the United States and Europe. The primary endpoint for the study will measure the change from worst itch at baseline in patients with moderate to severe uremic pruritus. Other secondary endpoints include patient perception of the burden of itch, quality of life effects of pruritus, and impact on sleep, anxiety and depression.
The study consists of a titration period of two weeks, followed by a six-week blinded period on a fixed dose of drug or placebo and a wash-out period. At the end of the wash-out period, patients are eligible to roll over into a six-month open label extension study. The Company expects topline data from this study in the third quarter of 2015.
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a late-stage clinical development company focused on developing Nalbuphine ER for chronic pruritus (itch). Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing two conditions for clinical development: uremic pruritus and prurigo nodularis. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with increased mortality. Prurigo nodularis is a chronic dermatologic condition characterized by severely pruritic nodules on the skin that are independent of underlying etiology. There are no approved therapies in the US or EU for either condition.
Nalbuphine ER is an oral extended release opioid with a dual mechanism of action, mu receptor antagonist and kappa receptor agonist, both of which have been shown in research to be effective in abolishing itch. Because of Nalbuphine ER’s unique dual mechanism of action, which has shown efficacy in addressing pruritus in both animal studies and human clinical trials, the company believes it can have broad utility in treating chronic pruritus.
Founded in 2011, Trevi is headquartered in New Haven, CT.
For additional information, visit www.trevitherapeutics.com.
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Media contact: Laura Brophy, (203) 331-7618 mediarelations@trevitherapeutics.com
Trevi Therapeutics Announces Initiation of a Pivotal Study of Nalbuphine ER in Prurigo Nodularis
Study will enroll 60 patients in the United States and Europe
New Haven, CT, March 11, 2015 – Trevi Therapeutics, Inc. (“Trevi” or the “Company”), a late stage clinical development company developing Nalbuphine ER for chronic pruritus conditions, today announced the initiation of the Company’s pivotal study of Nalbuphine ER in patients with prurigo nodularis, a severely pruritic dermatological condition characterized by itchy skin nodules. The Company is also currently conducting a pivotal trial with Nalbuphine ER in hemodialysis patients with uremic pruritus, which is almost fully enrolled.
Jennifer L. Good, Trevi’s President and Chief Executive Officer, said, “Prurigo nodularis is an intensely pruritic disease that seriously impacts a patient’s quality of life. There are no approved therapies for this condition. The initiation of this study of Nalbuphine ER is a significant step forward in the development of a potential therapeutic treatment option for these patients.”
Thomas R. Sciascia, M.D., Trevi’s Chief Medical Officer, said, “The hypothesis of our study is that within an eight-week period there will be a significant reduction in itch. We are also offering a one-year open label extension to understand if a prolonged reduction in itching will result in the healing of the skin.”
The multi-center, randomized, double-blind, placebo-controlled, parallel, three-arm study will evaluate the safety and anti-pruritic efficacy of Nalbuphine HCl ER tablets in approximately 60 prurigo nodularis patients. The study will be conducted in the United States and Europe. The primary endpoint for the study will measure the change in itch from baseline in prurigo nodularis patients with moderate to severe itch. The study also includes other secondary endpoints, including patient perception of the burden of itch, quality of life effects of pruritus, and impact on sleep, anxiety and depression.
The study will consist of a titration period of two weeks, followed by an eight-week blinded period on a fixed dose of drug or placebo and a two-week wash-out period. At the end of the wash-out period, patients may be eligible to roll over into a one-year open label extension study. For more information on the Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis, visit ClinicalTrials.gov. The Company expects topline data from this study in the third quarter of 2015.
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a late-stage clinical development company focused on developing Nalbuphine ER for chronic pruritus (itch). Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing two conditions for clinical development: uremic pruritus and prurigo nodularis. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with increased mortality. Prurigo nodularis is a chronic dermatologic condition characterized by severely pruritic nodules on the skin that are independent of underlying etiology. There are no approved therapies in the US or EU for either condition.
Nalbuphine ER is an oral extended release opioid with a unique opioid receptor dual agonist/antagonist mechanism of action, which has shown efficacy in addressing pruritus in both animal studies and human clinical trials. Because of Nalbuphine ER’s dual mechanism of action, the Company believes it can have broad utility in treating chronic pruritus.
Founded in 2011, Trevi is headquartered in New Haven, CT.
For additional information, visit www.trevitherapeutics.com.
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Media contact: Laura Brophy, (203) 331-7618, mediarelations@trevitherapeutics.com
Trevi Therapeutics to Present at the Annual Cowen and Company Healthcare Conference
New Haven, CT, February 23, 2015 – Trevi Therapeutics, Inc. (“Trevi”), a late-stage clinical development company focused on developing Nalbuphine ER for chronic pruritus conditions, today announced that Jennifer Good, President and Chief Executive Officer, will present a corporate overview of Trevi at the Cowen and Company 35th Annual Health Care Conference, March 2-4, 2015 at The Boston Marriott Copley Place. Ms. Good will present on Monday, March 2nd at 10:00 am.
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a late-stage clinical development company focused on developing Nalbuphine ER for chronic pruritus (itch). Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing two conditions for clinical development: uremic pruritus and prurigo nodularis. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with increased mortality. Trevi initiated a pivotal trial in uremic pruritus in mid-2014 and expects to report results in mid 2015. Prurigo nodularis is a chronic dermatologic condition characterized by severely pruritic nodules on the skin that are independent of underlying etiology. There are no approved therapies in the US or EU for either condition.
Nalbuphine ER is an oral extended release opioid with a unique opioid receptor dual agonist/antagonist mechanism of action, which has shown efficacy in addressing pruritus in both animal studies and human clinical trials. Because of Nalbuphine ER’s dual mechanism of action, the Company believes it can have broad utility in treating chronic pruritus. Founded in 2011, Trevi is headquartered in New Haven, CT.
For additional information, visit www.trevitherapeutics.com.
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Media contact: Laura Brophy, (203) 331-7618, mediarelations@trevitherapeutics.com
Trevi Therapeutics Closes $15 Million Debt Facility Provided by Solar Capital and Square 1 Bank
New Haven, CT – January 8, 2015 – Trevi Therapeutics, Inc. (“Trevi”), a late-stage clinical development company focused on developing Nalbuphine ER for chronic pruritus conditions, today announced the closing of a $15 million senior secured term loan agreement provided by Solar Capital Ltd. (“Solar Capital”) as collateral agent and lender and Square 1 Bank as lender.
“This financing is an important step for Trevi as we complete the funding for our ongoing clinical trials of Nalbuphine ER in uremic pruritus and prurigo nodularis,” said Jennifer Good, President and CEO.
“Trevi is developing therapeutic alternatives for the relief of severe chronic itch conditions which currently have no approved therapies in the US,” said Anthony Storino, head of healthcare venture lending at Solar Capital. “Solar Capital is pleased to lead this financing to support the company’s ongoing development efforts.”
“Square 1 is proud to partner with Trevi as they continue to move their trials forward in this important area of unmet need,” added Mara Huntington, senior vice president at Square 1 Bank. “Supporting therapeutics that improve patient quality of life is important to us at Square 1.”
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a late-stage clinical development company focused on developing Nalbuphine ER for chronic pruritus (itch). Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing two conditions for clinical development: uremic pruritus and prurigo nodularis. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with increased mortality. Trevi initiated a pivotal trial in uremic pruritus in mid-2014 and expects to report results in mid-2015. Prurigo nodularis is a chronic dermatologic condition characterized by severely pruritic nodules on the skin that are independent of underlying etiology. There are no approved therapies in the US or EU for either condition.
Nalbuphine ER is an oral extended release opioid with a unique opioid receptor dual agonist/antagonist mechanism of action, which has shown efficacy in addressing pruritus in both animal studies and human clinical trials. Because of Nalbuphine ER’s dual mechanism of action, the company believes it can have broad utility in treating chronic pruritus. Founded in 2011, Trevi is headquartered in New Haven, CT.
For additional information, visit www.trevitherapeutics.com.
About Solar Capital Ltd.
Solar Capital Ltd. (ticker: SLRC) is a closed-end investment company that has elected to be treated as a business development company under the Investment Company Act of 1940. Solar Capital primarily invests in leveraged, middle market companies in the form of senior secured loans, unitranche loans, mezzanine loans, and equity securities. Solar Capital Partners, the investment advisor to Solar Capital Ltd., has invested approximately $4.5 billion in more than 170 different portfolio companies since it was founded in 2006 and completed transactions with more than 100 different financial sponsors and venture capital firms.
Solar Capital’s healthcare lending segment provides financing solutions for bio-pharma, medical device, healthcare IT and healthcare services companies, both venture-backed private and public, and from pre-revenue clinical to commercial stage.
About Square 1 Bank
Square 1 Bank (ticker: SQBK) is a full service commercial bank dedicated exclusively to serving the financial needs of the venture capital community and entrepreneurs in all stages of growth and expansion. Square 1’s expertise, focus and strong capital base provide flexible resources and unmatched support to meet our clients’ needs. Square 1 has offices coast-to-coast in Austin, the Bay Area, Boston, Denver, Durham, Los Angeles/Orange County, New York, San Diego, Seattle, Silicon Valley and Washington, DC. For more information, visit www.square1bank.com.
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Media contacts:
Trevi Therapeutics: Laura Brophy, (203) 331-7618, mediarelations@trevitherapeutics.com
Solar Capital: Richard Pivirotto, 212-994-8543, pivirotto@solarcapltd.com
Square 1 Bank: Dee McDougal, 919-597-7479, dmcdougal@square1bank.com
Trevi Therapeutics to Present at the J.P. Morgan Healthcare Conference
New Haven, CT, January 5, 2015 – Trevi Therapeutics, Inc. (“Trevi”), a late-stage clinical development company focused on developing Nalbuphine ER for chronic pruritus conditions, today announced that Jennifer Good, President and Chief Executive Officer, will present a corporate overview of Trevi at the 33rd Annual J.P. Morgan Healthcare Conference at the Westin St. Francis Hotel in San Francisco, CA on Thursday, January 15, 2015 at 8:30 am ET.
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a late-stage clinical development company focused on developing Nalbuphine ER for chronic pruritus (itch). Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing two conditions for clinical development: uremic pruritus and prurigo nodularis. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with increased mortality. Trevi initiated a pivotal trial in uremic pruritus in mid-2014 and expects to report results in mid 2015. Prurigo nodularis is a chronic dermatologic condition characterized by severely pruritic nodules on the skin that are independent of underlying etiology. There are no approved therapies in the US or EU for either condition.
Nalbuphine ER is an oral extended release opioid with a unique opioid receptor dual agonist/antagonist mechanism of action, which has shown efficacy in addressing pruritus in both animal studies and human clinical trials. Because of Nalbuphine ER’s dual mechanism of action, the company believes it can have broad utility in treating chronic pruritus. Founded in 2011, Trevi is headquartered in New Haven, CT.
For additional information, visit www.trevitherapeutics.com.
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Media contact: Laura Brophy, (203) 331-7618, mediarelations@trevitherapeutics.com
Trevi Therapeutics to Present at the Stifel 2014 Healthcare Conference
New Haven, CT, November 17, 2014 – Trevi Therapeutics, Inc. (“Trevi”), a late-stage clinical development company focused on developing Nalbuphine ER for chronic pruritus conditions, today announced that Jennifer Good, President and Chief Executive Officer, will present at the Stifel 2014 Healthcare Conference in New York City on Wednesday, November 19, 2014 at 8:00 am ET, where she will discuss Trevi’s corporate strategy, recent Nalbuphine ER data and current pending pivotal trials in uremic pruritus and prurigo nodularis.
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a late-stage clinical development company focused on developing Nalbuphine ER for chronic pruritus (itch). Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing two conditions for clinical development: uremic pruritus and prurigo nodularis. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with increased mortality. Trevi initiated a pivotal trial in uremic pruritus in mid-2014 and expects to report results in mid 2015. Prurigo nodularis is a chronic dermatologic condition characterized by severely pruritic nodules on the skin that are independent of underlying etiology. There are no approved therapies in the US or EU for either condition.
Nalbuphine ER is an oral extended release opioid with a unique opioid receptor dual agonist/antagonist mechanism of action, which has shown efficacy in addressing pruritus in both animal studies and human clinical trials. Because of Nalbuphine ER’s dual mechanism of action, the company believes it can have broad utility in treating chronic pruritus. Founded in 2011, Trevi is headquartered in New Haven, CT.
For additional information, visit www.trevitherapeutics.com.
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Media contact: Laura Brophy, (203) 331-7618, mediarelations@trevitherapeutics.com
Trevi Therapeutics Selected to Exhibit Poster at American Society of Nephrology Kidney Week 2014
Title of Abstract: Exploring Clinical and Pharmacological Effects of Nalbuphine HCl Oral Tablets in Hemodialysis Subjects with Pruritus
New Haven, CT, November 11, 2014 – Trevi Therapeutics, Inc. (“Trevi”), a late-stage clinical development company focused on developing Nalbuphine ER for chronic pruritus conditions, was selected to exhibit a poster at the American Society of Nephrology’s Kidney Week 2014, which takes place November 13th-16th at the Pennsylvania Convention Center in Philadelphia, PA.
Poster #TH-PO730, titled “Exploring Clinical and Pharmacological Effects of Nalbuphine HCl Oral Tablets in Hemodialysis Subjects with Pruritus,” reports that Nalbuphine administered as oral nalbuphine HCl ER tablets was safe and well tolerated up to 240 mgs and that there appeared to be a dose-dependent reduction in VAS scores related to itch.
Thomas Sciascia, MD, Trevi’s Chief Medical Officer and the lead author on the paper, will be present at the poster during the Novel Interventions and Screening Approaches to Prevent CKD session, which will take place on Thursday, November 13, from 10:00 AM – 12:00 PM.
Dr. Sciascia said, “We were pleased to learn that Nalbuphine ER appears to be well tolerated in renally impaired patients and that the pharmacokinetics of the drug were not affected by the dialysis process. Also, we believe the proof-of-concept, as measured by the reduction in itch, was compelling and consistent across the patients in the study. Based on this data, we have initiated a pivotal study in uremic pruritus in 360 patients in the U.S. and Europe, which we expect to report out in mid-2015.”
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a late-stage clinical development company focused on developing Nalbuphine ER for chronic pruritus (itch). Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing two conditions for clinical development: uremic pruritus and prurigo nodularis. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with increased mortality. Trevi initiated a pivotal trial in uremic pruritus in mid-2014 and expects to report results in mid 2015. Prurigo nodularis is a chronic dermatologic condition characterized by severely pruritic nodules on the skin that are independent of underlying etiology. There are no approved therapies in the US or EU for either condition.
Nalbuphine ER is an oral extended release opioid with a unique opioid receptor dual agonist/antagonist mechanism of action, which has shown efficacy in addressing pruritus in both animal studies and human clinical trials. Because of Nalbuphine ER’s dual mechanism of action, the company believes it can have broad utility in treating chronic pruritus. Founded in 2011, Trevi is headquartered in New Haven, CT.
For additional information, visit www.trevitherapeutics.com.
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Media contact: Laura Brophy, (203) 331-7618, mediarelations@trevitherapeutics.com
Trevi Therapeutics Announces Second Closing of $26 Million Series B Financing for Development of Nalbuphine ER
Uremic pruritus trial enrolling ahead of schedule and Company preparing to initiate trial in prurigo nodularis
New Haven, CT, November 6, 2014 – Trevi Therapeutics, Inc. (“Trevi” or the “Company”), a development-stage biotechnology company developing Nalbuphine ER for severe chronic pruritus conditions, today announced the second and final closing of $11 million in a Series B financing of $26 million led by TPG Biotech, the life science venture investment arm of TPG, and existing angel investors.
The Company is continuing enrollment in the U.S. for its uremic pruritus trial, a pivotal study expected to enroll approximately 360 patients, and expects to initiate enrollment at European sites for this study by year-end. Trevi also anticipates initiating a pivotal trial in prurigo nodularis this quarter.
Jennifer L. Good, Trevi’s President and Chief Executive Officer, said, “We are very encouraged by the enrollment rate in our pivotal trial in uremic pruritus. It has validated for us that a significant unmet medical need exists for patients undergoing hemodialysis who suffer from chronic pruritus. We expect the enrollment rate to accelerate as our European sites come on board by year-end. With TPG Biotech’s continued financial support, we anticipate that we will achieve top-line results for this trial earlier than expected, with results in mid-2015.”
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a development-stage biotechnology company focused on developing Nalbuphine ER for chronic pruritus (itch). Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing two conditions for clinical development: uremic pruritus and prurigo nodularis. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with increased mortality. Prurigo nodularis is a chronic dermatologic condition characterized by severely pruritic nodules on the skin that are independent of underlying etiology. There are no approved therapies in the US or EU for either condition.
Nalbuphine ER is an oral extended release opioid with a unique opioid receptor dual agonist/antagonist mechanism of action, which has shown efficacy in addressing pruritus in both animal studies and human clinical trials. Because of Nalbuphine ER’s dual mechanism of action, the company believes it can have broad utility in treating chronic pruritus.
Founded in 2011, Trevi is headquartered in New Haven, CT.
For additional information, visit www.trevitherapeutics.com.
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Media contact: Laura Brophy, (203) 331-7618, mediarelations@trevitherapeutics.com
Gil Yosipovitch, M.D. Joins Trevi Therapeutics Clinical Advisory Board
Noted pruritus key opinion leader is Director of the Temple Itch Center at the Temple University School of Medicine
New Haven, CT, October 1, 2014 – Trevi Therapeutics, Inc. (“Trevi”), a late-stage development biotechnology company developing Nalbuphine ER for chronic pruritus conditions, today announced that Gil Yosipovitch, M.D. has joined its Clinical Advisory Board. In that role, Dr. Yosipovitch, Professor and Chair of The Department of Dermatology and Director of the Temple Itch Center at the Temple University School of Medicine in Philadelphia, Pennsylvania, will work closely with Trevi’s Co-founders, Jennifer Good and Thomas Sciascia, M.D., on the Company’s development programs. Dr. Yosipovitch will join Dr. Jeffrey Bernhard, M.D., also a noted dermatologist and key opinion leader in pruritus, on the Company’s Clinical Advisory Board.
Thomas Sciascia, M.D., Trevi’s Chief Medical Officer, said, “Dr. Yosipovitch is one of the world’s experts in itch, and we are grateful to have his experience and counsel as we plan and conduct the pivotal clinical trials for Nalbuphine ER in uremic pruritus and prurigo nodularis. Itch is becoming increasingly recognized as an important unmet medical need, and we look forward to partnering with one of the innovators in this disease as we execute on our development programs for Nalbuphine ER.”
Dr. Yosipovitch said, “I look forward to working with the Trevi team to continue the development of Nalbuphine ER for the serious unmet medical needs in chronic pruritus. Given my previous research and clinical experience in itch, the dual mechanism of action for Nalbuphine ER is an exciting potential treatment pathway for these otherwise refractory types of pruritus, and the Company has already generated compelling clinical data to support this experience.”
Dr. Yosipovitch’s research studies focus on neurophysiology of itch and scratch, brain imaging of itch, skin innervation and sensory testing and developing and testing anti-pruritic drugs. He has published more than 250 articles in books and peer-reviewed journals. He is the founder and past president of the International Forum for The Study of Itch (IFSI), which is a multidisciplinary international association of clinicians and researchers dedicated to improving the understanding of itch. Dr. Yosipovitch has been awarded several prestigious awards for his research.
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a late-stage development biotechnology company focused on developing Nalbuphine ER for chronic pruritus (itch). Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing two conditions for clinical development: uremic pruritus and prurigo nodularis. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with increased mortality. Prurigo nodularis is a skin disease characterized by severely pruritic nodules on the skin. There are no approved therapies in the US or EU for either disease.
Nalbuphine ER is an oral extended release opioid with a unique opioid receptor dual agonist/antagonist mechanism of action, which has shown efficacy in addressing pruritus in both animal studies and human clinical trials. Because of Nalbuphine ER’s dual mechanism of action, the company believes it can have broad utility in treating chronic pruritus. Founded in 2011, Trevi is headquartered in New Haven, CT.
For additional information, visit www.trevitherapeutics.com.
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Media contact: Laura Brophy, (203) 331-7618, mediarelations@trevitherapeutics.com
Trevi Therapeutics Selected to Exhibit Poster at 2014 Annual Meeting of the American College of Clinical Pharmacology
Title of Abstract: Pharmacokinetics of Nalbuphine Hydrochloride Extended Release Tablets in Hemodialysis and Healthy Subjects following Multiple Escalating Oral Doses
New Haven, CT, September 9, 2014 – Trevi Therapeutics, Inc. (“Trevi”), a late-stage biotechnology company developing Nalbuphine ER for chronic pruritus conditions, was selected to exhibit a poster at the 2014 Annual Meeting of the American College of Clinical Pharmacology, which takes place September 14th – 16th at the Westin Peachtree Plaza and AmericasMart in Atlanta, GA.
Poster #1998512, titled “Pharmacokinetics of Nalbuphine Hydrochloride Extended Release Tablets in Hemodialysis and Healthy Subjects following Multiple Escalating Oral Doses,” reports results from Trevi’s recently completed Phase 1 trial in renally impaired patients on hemodialysis. The poster’s first author, Amale Hawi, PhD, will be available at the poster on Tuesday, September 16, 2014, from 7:00-8:00 am to discuss the findings.
Thomas Sciascia, MD, Trevi’s co-founder and Chief Medical Officer, said, “Opioids have not historically been well characterized in renally impaired patients. This rigorous study characterized the pharmacokinetics of Nalbuphine ER in renally impaired patients, established that the drug was well tolerated across the entire dose range, and demonstrated the drug is not affected by the dialysis process. We also observed compelling proof-of-concept data in the reduction of itching over the two-week period in the hemodialysis patients. This study was the basis for the pivotal study in patients with moderate to severe uremic pruritus that we initiated this summer.”
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a late-stage biotechnology company focused on developing Nalbuphine ER for chronic pruritus (itch). Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing two conditions for clinical development: uremic pruritus and prurigo nodularis. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with increased mortality. Trevi initiated a pivotal trial in uremic pruritus in mid-2014 and expects to report results in the third quarter of 2015. Prurigo nodularis is a chronic dermatologic condition characterized by severely pruritic nodules on the skin that are independent of underlying etiology. There are no approved therapies in the US or EU for either condition.
Nalbuphine ER is an oral extended release opioid with a unique opioid receptor dual agonist/antagonist mechanism of action, which has shown efficacy in addressing pruritus in both animal studies and human clinical trials. Because of Nalbuphine ER’s dual mechanism of action, the company believes it can have broad utility in treating chronic pruritus. Founded in 2011, Trevi is headquartered in New Haven, CT.
For additional information, visit www.trevitherapeutics.com.
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Media contact: Laura Brophy, (203) 331-7618, mediarelations@trevitherapeutics.com
Trevi Therapeutics Announces the Issuance of Two Patents Covering the Oral Sustained Release Formulation of Nalbuphine ER
Patent estate includes Method of Use and Formulation Patents
New Haven, CT, August 14, 2014 – Trevi Therapeutics, Inc. (“Trevi”), a clinical stage biotechnology company developing Nalbuphine ER for chronic pruritus conditions, today announced that it has received two issued U.S. patents with claims protecting the oral sustained release formulation of nalbuphine. The patent numbers are 8,771,732 and 8,765,175.
The Company believes that both of these patents will be Orange Book-listable. These two patents complement two additional issued formulation patents, as well as an issued patent protecting the method of use of Nalbuphine ER in the “Methods for Treatment of Pruritus,” which expires in December 2032. Trevi continues to prosecute additional claims to further enhance its existing patent estate protecting Nalbuphine ER in itch.
Jennifer Good, Trevi’s President and Chief Executive Officer, said, “We are pleased with the issued patent estate to date and will continue to pursue opportunities to protect Nalbuphine ER. Nalbuphine’s novel mechanism of action aligns well with multiple itch conditions, and we have initiated a pivotal trial in uremic pruritus and will be initiating a pivotal trial in prurigo nodularis later this year.”
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a clinical stage biotechnology company focused on developing Nalbuphine ER for chronic pruritus (itch). Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing two conditions for clinical development: uremic pruritus and prurigo nodularis. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with increased mortality. Prurigo nodularis is a chronic dermatologic condition characterized by severely pruritic nodules on the skin that are independent of underlying etiology. There are no approved therapies in the US or EU for either condition.
Nalbuphine ER is an oral extended release opioid with a unique opioid receptor dual agonist/antagonist mechanism of action, which has shown efficacy in addressing pruritus in both animal studies and human clinical trials. Because of Nalbuphine ER’s dual mechanism of action, the company believes it can have broad utility in treating chronic pruritus. Founded in 2011, Trevi is headquartered in New Haven, CT.
For additional information, visit www.trevitherapeutics.com.
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Media contact: Laura Brophy, (203) 331-7618, mediarelations@trevitherapeutics.com
Trevi Therapeutics Announces Initiation of a Pivotal Study of Nalbuphine ER in Uremic Pruritus
Study will enroll 360 patients in the United States and Europe
New Haven, CT, July 14, 2014 – Trevi Therapeutics, Inc. (“Trevi” or the “Company”), a clinical stage biotechnology company developing Nalbuphine ER for chronic pruritus conditions, today announced the first patient enrolled in the pivotal study of Nalbuphine ER in hemodialysis patients with uremic pruritus. The Company recently released data from its successfully completed Phase 1 trial in which Nalbuphine ER was well tolerated in hemodialysis patients and established proof-of-concept for Nalbuphine ER in treating uremic pruritus.
Jennifer L. Good, Trevi’s President and Chief Executive Officer, said, “Approximately 40% of hemodialysis patients have moderate to severe pruritus that significantly impacts their quality of life. There are no approved therapies for this condition. The initiation of this pivotal study of Nalbuphine ER is a significant step forward in the development of a potential therapeutic treatment option for these patients.”
Thomas R. Sciascia, M.D., Trevi’s Chief Medical Officer, said, “There has been a significant amount of research done over a number of years hypothesizing that the mu antagonist/kappa agonist mechanism could be a good treatment option for patients suffering from chronic pruritus. This study is an important step in advancing the research that has been done around the world in chronic pruritus.”
The multi-center, randomized, double-blind, placebo-controlled, parallel, three-arm study will evaluate the safety and anti-pruritic efficacy of Nalbuphine ER tablets in approximately 360 hemodialysis patients. The study will be conducted in the United States and Europe. The primary endpoint for the study will measure the change from worst itch at baseline in patients with moderate to severe uremic pruritus, treated with two doses of Nalbuphine ER. The study also includes other secondary endpoints, including patient perception of the burden of itch, quality of life effects of pruritus, and impact on sleep, anxiety and depression.
The study will consist of a titration period of two weeks, followed by a six week blinded period on a fixed dose of drug or placebo and a wash-out period. At the end of the wash-out period, patients may be eligible to roll over into a six month open label extension study. The Company expects topline data from this study in the fourth quarter of 2015.
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a clinical stage biotechnology company focused on developing Nalbuphine ER for chronic pruritus (itch). Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing two conditions for clinical development: uremic pruritus and prurigo nodularis. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with increased mortality. Prurigo nodularis is a chronic dermatologic condition characterized by severely pruritic nodules on the skin that are independent of underlying etiology. There are no approved therapies in the US or EU for either condition.
Nalbuphine ER is an oral extended release opioid with a unique opioid receptor dual agonist/antagonist mechanism of action, which has shown efficacy in addressing pruritus in both animal studies and human clinical trials. Because of Nalbuphine ER’s dual mechanism of action, the company believes it can have broad utility in treating chronic pruritus.
Founded in 2011, Trevi is headquartered in New Haven, CT.
For additional information, visit www.trevitherapeutics.com.
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Media contact: Laura Brophy, (203) 331-7618, mediarelations@trevitherapeutics.com
Trevi Therapeutics Announces $25 Million Series B Financing Led by TPG Biotech for Development of Nalbuphine ER
Company initiating activities for pivotal trials in chronic pruritic conditions of uremic pruritus and prurigo nodularis
New Haven, CT, June 4, 2014 – Trevi Therapeutics, Inc. (“Trevi” or the “Company”), a clinical stage biotechnology company developing Nalbuphine ER for chronic pruritus conditions, today announced a Series B financing of $25 million led by TPG Biotech, the life science venture investment arm of TPG, with $15 million funded at first closing. TPG Biotech previously invested $12.8 million in the Company, and along with the Company’s angel investors, has financed the Company since inception.
The Company plans to use the funding for the initiation of pivotal trials in two severe itch conditions: uremic pruritus and prurigo nodularis. The Company recently released data from its successfully completed Phase 1 trial in which Nalbuphine ER was shown to be well tolerated in patients on hemodialysis with itch and established proof-of-concept in uremic pruritus. The Company intends to initiate both pivotal trials in the third quarter of this year, and expects to have top-line results in the second half of 2015.
Jennifer L. Good, Trevi’s President and Chief Executive Officer, said, “Since receiving Series A financing 18 months ago, the Company has generated compelling proof of concept safety and efficacy data for Nalbuphine ER in itch, including most recently in uremic pruritus. This recent data established initial safety in renally impaired patients, and 12 out of the 14 patients dosed with Nalbuphine ER indicated a dose-dependent reduction in VAS scores measuring itch. We continue to believe that the dual mechanism of action of nalbuphine is uniquely suited to treating many itch conditions.”
Eran Nadav, Ph.D., Managing Director at TPG Biotech and Trevi’s Chairman, said, “We have been very pleased with the progress the Trevi team has made in rapidly advancing Nalbuphine ER for chronic pruritus. Chronic pruritus is a significant unmet medical need, and we believe that mechanistically, and based on the recent data generated in the Phase 1 trial, Nalbuphine ER has a good chance of providing safe and effective therapy for these patients. We will continue to support Trevi as it moves through this next important phase of development.”
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a clinical stage biotechnology company focused on developing Nalbuphine ER for chronic pruritus (itch). Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing two conditions for clinical development: uremic pruritus and prurigo nodularis. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with increased mortality. Prurigo nodularis is a chronic dermatologic condition characterized by severely pruritic nodules on the skin that are independent of underlying etiology. There are no approved therapies in the US or EU for either condition.
Nalbuphine ER is an oral extended release opioid with a unique opioid receptor dual agonist/antagonist mechanism of action, which has shown efficacy in addressing pruritus in both animal studies and human clinical trials. Because of Nalbuphine ER’s dual mechanism of action, the company believes it can have broad utility in treating chronic pruritus.
Founded in 2011, Trevi is headquartered in New Haven, CT.
For additional information, visit www.trevitherapeutics.com.
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Media contact: Laura Brophy, (203) 331-7618, mediarelations@trevitherapeutics.com
Trevi Therapeutics Exhibits Poster at 2014 Annual Meeting of the Society for Investigative Dermatology
Proof-of-concept study with pharmacokinetics demonstrates anti-pruritic activity of oral nalbuphine ER in hemodialysis patients with uremic pruritus
New Haven, CT, May 9, 2014 – Trevi Therapeutics, Inc. (“Trevi”), a clinical stage biotechnology company developing Nalbuphine ER for chronic pruritus conditions, will exhibit a poster with the results of a recently completed Phase 1 proof-of-concept study at the 2014 Annual Meeting of the Society for Investigative Dermatology in Albuquerque, NM being held May 7-10.
Poster #567, titled “A proof-of-concept study with pharmacokinetics demonstrating anti-pruritic activity of oral nalbuphine in hemodialysis patients with uremic pruritus,” will be displayed at the Society for Investigative Dermatology meeting being held in Albuquerque, New Mexico. The poster reports results from Trevi’s recently completed Phase 1 study which studied the impact on uremic pruritus following oral administration of Nalbuphine ER in fourteen hemodialysis subjects with pruritus. Nalbuphine ER was dose escalated every three days from 30 mg to 240 mg BID over 17 days. A dose-dependent decrease in itch was noted in 13 out of 14 patients. The study appears to establish a relationship between AUC, Cmax, and Cmin and change in VAS score.
Thomas Sciascia, MD, Trevi’s co-founder and Chief Medical Officer, said “Nalbuphine ER was shown to be well tolerated in patients on hemodialysis with itch and established proof-of-efficacy in uremic pruritus. We also established safety across a broad dose range. We are advancing Nalbuphine ER in development, and will initiate two efficacy trials in mid-2014 to determine its effectiveness in treating two debilitating medical conditions: uremic pruritus and prurigo nodularis.”
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a clinical stage biotechnology company focused on developing Nalbuphine ER for chronic pruritus (itch). Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing two conditions for clinical development: uremic pruritus and prurigo nodularis. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with increased mortality. Prurigo nodularis is a chronic dermatologic condition characterized by severely pruritic nodules on the skin that are independent of underlying etiology. There are no approved therapies in the US or EU for either condition.
Nalbuphine ER is an oral extended release opioid with a unique opioid receptor dual agonist/antagonist mechanism of action, which has shown efficacy in addressing pruritus in both animal studies and human clinical trials. Because of Nalbuphine ER’s dual mechanism of action, the company believes it can have broad utility in treating chronic pruritus. Founded in 2011, Trevi is headquartered in New Haven, CT.
For additional information, visit www.trevitherapeutics.com.
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Media contact: Laura Brophy, (203) 331-7618, mediarelations@trevitherapeutics.com
Trevi Therapeutics Presents Data at the 7th World Congress on Itch
Nalbuphine attenuates itch in the substance P-induced mouse model
New Haven, CT, September 25, 2013 – Trevi Therapeutics, Inc. (“Trevi”), a clinical stage biotechnology company focused on developing Nalbuphine ER for chronic pruritus, presented data on nalbuphine at the 7th World Congress on Itch.
Nalbuphine is a mixed mu antagonist/kappa agonist opioid. The effect of nalbuphine on substance-P induced scratching was studied by Trevi in the mouse model. This model is relevant to antihistamine-resistant pruritus, which is observed in patients with various dermatopathologies. Following substance-P administration in the untreated mice, itching began within 3-5 minutes from the pruritogen administration with the highest itch intensity in the first 30 minutes post substanc-P injection. Following nalbuphine administration, a significant reduction in itch (p<0.001) was noted with a 43% reduction in itch at the 10 mg/kg dose and a 51% reduction at the 30 mg/kg dose.
The published literature on nalbuphine suggests a centrally mediated effect. The substance-P mouse model conducted by Trevi suggests nalbuphine can be effective as well in the treatment of peripherally mediated pruritic conditions. This evidence of a centrally and peripherally mediated effect potentially makes Nalbuphine ER a good therapy for various chronic pruritic conditions.
Thomas Sciascia, MD, Trevi’s co-founder and Chief Medical Officer, said, “We are currently completing a Phase 1 trial in renally impaired patients to establish safety in this patient population, and are preparing to initiate an efficacy study in uremic pruritus in the first half of 2014. In parallel, we plan to initiate a Phase 2 study in a serious dermatologic condition, prurigo nodularis, in the same time period.”
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a clinical stage biotechnology company focused on developing Nalbuphine ER for chronic pruritus (itch). Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing two conditions for clinical development: uremic pruritus and prurigo nodularis. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with increased mortality. Prurigo nodularis is a chronic dermatologic condition characterized by pruritic nodules on the skin that are independent of underlying etiology, but instead result as a clinical reaction pattern due to long-term trauma of the pruritic skin.
Nalbuphine ER is an oral extended release opioid with a unique opioid receptor dual agonist/antagonist mechanism of action, which has been shown in both animal studies and human clinical trials as being effective in pruritus. Because of Nalbuphine ER’s dual mechanism of action, the company believes it can have broad utility in treating chronic pruritus. Founded in 2011, Trevi is headquartered in New Haven, CT.
For additional information, visit www.trevitherapeutics.com.
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Media contact: Laura Brophy, (203) 331-7618, mediarelations@trevitherapeutics.com
Trevi Therapeutics Commences Clinical Study of Nalbuphine ER
Phase 1 Study in End-Stage Renal Disease Patients on Hemodialysis
New Haven, CT, May 6, 2013 – Trevi Therapeutics, Inc. (“Trevi”), a drug development company focused on developing Nalbuphine ER for chronic pruritus, announced today that it has commenced a Phase 1, open-label study to characterize and compare the pharmacokinetics, safety and tolerability of escalating oral doses of nalbuphine hydrochloride extended release tablets in end-stage renal disease patients on hemodialysis as compared to healthy control subjects. The study will include 20 subjects and top-line data is expected by year-end.
Nalbuphine ER is an oral extended release formulation of nalbuphine hydrochloride which has previously only been approved as an injectable. Nalbuphine has a unique opioid receptor dual agonist/antagonist mechanism of action and has been shown in both animal and human clinical studies as being effective in pruritus. Because of the drug’s centrally acting dual mechanism of action, the Company believes Nalbuphine ER may have broad utility in treating chronic pruritus.
Jennifer Good, Trevi’s Co-founder and President and CEO, said, “We have strong momentum inside Trevi as we initiate this important trial to establish the safety of Nalbuphine ER in the intended patient population of renally impaired patients and prepare to initiate an efficacy study in uremic pruritus in early 2014. We are also actively pursing a second indication in dermatology and anticipate initiating that efficacy trial next year as well.”
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a drug development company focused on developing Nalbuphine ER for chronic pruritus (itch). Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing uremic pruritus as the lead indication. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with increased mortality. Nalbuphine ER is an oral extended release opioid with a unique opioid receptor dual agonist/antagonist mechanism of action, which has been shown in both animal and human clinical studies as being effective in pruritus. Because of Nalbuphine ER’s centrally acting dual mechanism of action, the company believes it can have broad utility in treating chronic pruritus and is actively pursuing a second indication in dermatology. Founded in 2011, Trevi is headquartered in New Haven, CT.
For additional information, visit www.trevitherapeutics.com.
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Media contact: Laura Brophy, (203) 331-7618, mediarelations@trevitherapeutics.com
Trevi Therapeutics Names William J. O’Shea to Board and Establishes a Clinical Advisory Board
Company also completes move to New Haven, CT
New Haven, CT, March 26, 2013 – Trevi Therapeutics, Inc., (“Trevi”) a drug development company focused on developing Nalbuphine ER for pruritus, announced today that it has named William J. O’Shea to its Board of Directors and established a Clinical Advisory Board to provide clinical and scientific input into the development strategy for Nalbuphine ER.
Mr. O’Shea comes to Trevi’s Board with strong executive and commercial experience. He was President and Chief Operating Officer of Sepracor, Inc. from 1999-2007 and spent an additional year as Vice Chairman. Earlier, he was Senior Vice President of Sales & Marketing and Medical Affairs for Zeneca Pharmaceuticals (US). Mr. O’Shea was an original angel investor in Trevi and has been involved with the Company since its inception. Trevi’s Board currently includes two representatives of TPG Biotech, Eran Nadav, PhD and Cayce Denton, as well as Jennifer L. Good, Trevi’s Co-founder, President and CEO.
The Clinical Advisory Board will be chaired by Trevi’s Chief Medical Officer, Dr. Thomas Sciascia, and will also include Dr. Jeffrey Bernhard and Dr. Dawn McGuire.
Dr. Bernhard is a board-certified dermatologist who is currently in private practice. He is a professor emeritus of medicine at the University of Massachusetts Medical School in Worcester. After 10 years as editor-in-chief, he is now editor emeritus of the Journal of the American Academy of Dermatology. Dr. Bernhard graduated from Harvard College, was a Knox Fellow at St. John’s College, Cambridge, and then earned his MD at Harvard Medical School.
Dr. McGuire is a board-certified neurologist and Fellow of the Academy of Neurology, and serves on the faculty of the Neuroscience Institute of the Morehouse School of Medicine. Dr. McGuire was previously the Chief Medical Officer for Acologix, where she worked on the development of a compound in uremic pruritus as well as the only longitudinal study in uremic pruritus. Dr. McGuire holds a BA with High Honors from Princeton University, a Masters in Divinity from Union Theological Seminary and an MD from Columbia University College of Physicians & Surgeons.
Jennifer Good said, “We are pleased to be adding depth both commercially and scientifically within Trevi. Jim brings a strong commercial background and executive pharma experience to the Trevi Board of Directors. We also welcome both Jeff and Dawn to the Clinical Advisory Board and welcome their depth of clinical and drug development experience as we move forward with the clinical development of Nalbuphine ER and maximizing the value of Trevi.”
In addition, Trevi also announced that it completed its move to offices in New Haven, CT, which is a growing area for biotech companies due to the depth of science, pharmaceutical and biotech resources in the area.
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a drug development company focused on developing Nalbuphine ER for severe chronic pruritus (itch). Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing uremic pruritus as the lead indication. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with increased mortality. Nalbuphine ER is an oral extended release opioid with a unique dual agonist/antagonist mechanism of action, which has been shown in both animal and human clinical studies as being effective in pruritus. Founded in 2011, Trevi is headquartered in New Haven, CT.
For additional information, visit www.trevitherapeutics.com.
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Media contact: Laura Brophy, (203) 331-7618, mediarelations@trevitherapeutics.com
Trevi Therapeutics Announces $10 Million Series A Financing from TPG Biotech
Company is focused on developing T111 for uremic pruritus and other itching conditions
New Haven, CT, December 18, 2012—Trevi Therapeutics, Inc. (“Trevi”) today announced the closing of a $10 million Series A financing to advance the clinical development of T111 in the lead indication of uremic pruritus. The Series A investment was completed with TPG Biotech, the life science venture investment arm of TPG which had previously made a seed investment in the Company.
With the proceeds from the Series A investment, Trevi intends to advance T111, an oral extended release opioid with a unique agonist/antagonist mechanism of action, into clinical development for the treatment of uremic pruritus. Uremic pruritus is a persistent and debilitating itching in patients on dialysis that has been linked to increased mortality. Currently, there are no approved drug therapies for the treatment of uremic pruritus in the U.S. or Europe.
“I am very pleased to have TPG Biotech as a partner as we continue the development of T111 in this serious medical condition,” said Jennifer Good, Trevi’s President and Chief Executive Officer. “Treatment of chronic skin itching is a significant unmet clinical need, and we believe that the unique dual mechanism of action of T111 could have broad applicability in the pruritus market. We plan to initiate an efficacy clinical trial in uremic pruritus patients in the first quarter of 2014.”
Eran Nadav, Ph.D., Managing Director at TPG Biotech, added, “TPG is delighted to back the Trevi team. The potential of T111 to relieve pruritus is supported by solid scientific data, and we believe it represents an interesting market opportunity.”
Trevi was founded in 2011 by Ms. Good and Dr. Thomas Sciascia, who, together, previously formed the executive management team at Penwest Pharmaceuticals. Prior to the Series A investment, Trevi received funding from angel investors as well as a seed investment from TPG Biotech to conduct pre-clinical testing, regulatory activities, initial clinical planning and the prosecution of the Company’s intellectual property. Joining Ms. Good on Trevi’s Board of Directors are Eran Nadav, Ph.D. and Cayce Denton, from TPG Biotech. The company will be located in New Haven, CT.
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a drug development company founded in 2011 focused on developing T111 for the severe chronic itching condition known as pruritus. Pruritus is manifested in various dermatological, metabolic, hematologic and neuronal conditions. The Company is pursuing uremic pruritus as the lead indication. Uremic pruritus is a persistent and debilitating itching in patients on dialysis that has been linked to increased mortality. T111 is an oral extended release opioid with a unique dual agonist/antagonist mechanism of action, which has been shown in both animal and human clinical studies as being effective in pruritus.
For additional information, visit www.trevitherapeutics.com.
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Media contact: Laura Brophy, (203) 331-7618, mediarelations@trevitherapeutics.com
Trevi Therapeutics Announces Incorporation and Phase 2 Development of T111
Company developing its lead compound in chronic uremic pruritus
SANDY HOOK, CT, September 27, 2011—Trevi Therapeutics, Inc. announces its incorporation and the initiation of development of T111 for chronic uremic pruritus. The Company is seeking orphan drug designation for this compound in both the US and Europe, and is also prosecuting patent applications.
Trevi was founded in 2011 as a drug development company focused on developing compounds primarily for orphan diseases with unmet medical needs. The company was co-founded by Jennifer L. Good and Thomas R. Sciascia, MD, the former executive management team at Penwest Pharmaceuticals, which was acquired by its partner, Endo Pharmaceuticals, in the fourth quarter of 2010. Ms. Good will serve as Trevi’s President and CEO and Dr. Sciascia will serve as the Company’s Chief Medical Officer.
Trevi’s lead compound, T111, is entering Phase 2 development and is targeted at treating chronic uremic pruritus, a persistent form of itching in patients on hemodialysis. Currently, there are no approved drug therapies in either the US or Europe for chronic uremic pruritus, of which the Company believes there are approximately 170,000 patients in the US and 135,000 patients in Europe.
“Trevi’s development strategy reflects our belief in the value of orphan drug development,” Ms. Good said. “There are vast unmet medical needs in orphan diseases, and we believe small, focused drug development companies like Trevi are uniquely suited to advance these compounds efficiently to points of proof of concept and value creation. We have been working diligently to complete the necessary steps to commence clinical trials, which we plan to initiate in the first quarter of 2012.”
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a drug development company founded in 2011 to develop compounds, primarily for orphan diseases with unmet medical needs. The Company’s lead compound, T111, is entering Phase 2 development and is targeted at treating chronic uremic pruritus, a persistent form of itching in kidney dialysis patients. The Company is seeking orphan drug designation in the US and Europe and is also prosecuting patent applications. The Company also intends to evaluate other orphan opportunities to add to its development pipeline.
For additional information, visit www.trevitherapeutics.com.
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Media contact: Laura Brophy, (203) 331-7618, mediarelations@trevitherapeutics.com