Passionate about Progress
We are developing nalbuphine ER to treat serious neurologically mediated conditions by targeting the central and peripheral nervous systems.
Nalbuphine ER is an oral, extended-release formulation of nalbuphine, which has a long history of efficacy and safety, having been approved for more than 20 years in the United States and Europe as a subcutaneous injection for relief of moderate to severe pain in the hospital setting. Our novel oral formulation has the potential to unlock new market opportunities and significantly improve the quality of life of patients who currently have few treatment options.
Nalbuphine has a dual mechanism of action, acting as both an antagonist (blocker) to the body’s mu opioid receptor and as an agonist (activator) to the kappa opioid receptor. The kappa and mu opioid receptors are known to be critical mediators of the urges to scratch and cough, as well as of certain movement disorders. Nalbuphine’s mechanism of action also mitigates the risk of abuse associated with mu opioid agonists because it blocks the mu opioid receptor. Nalbuphine is currently the only opioid approved for marketing that is not a controlled substance in the United States or Europe.
We are 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. Our pivotal Phase 2b/3 clinical trial of nalbuphine ER (PRISM) is currently enrolling patients with severe pruritus associated with prurigo nodularis (PN). In addition, we initiated a Phase 2 clinical trial of nalbuphine ER for the treatment of chronic cough in patients with IPF and we are preparing to initiate a Phase 2 clinical trial of nalbuphine ER for the treatment of LID in patients with Parkinson’s disease.
Board of Directors
David Meeker, M.D. – Chairman
James Cassella, Ph.D.
James Cassella, Ph.D. has served on or board of directors since February 2020. Dr. Cassella has served as Chief Development Officer for Concert Pharmaceuticals, Inc. since February 2015. Prior to joining Concert, Dr. Cassella served as Executive Vice President, Research and Development and Chief Scientific Officer of Alexza Pharmaceuticals, Inc. from July 2012 to January 2015 and served as its Senior Vice President, Research and Development from June 2004 to July 2012. From April 1989 to April 2004, Dr. Cassella held various management positions at Neurogen Corporation. Prior to Neurogen, Dr. Cassella was Assistant Professor of Neuroscience at Oberlin College. Dr. Cassella received a Ph.D. in Physiological Psychology from Dartmouth College, completed a postdoctoral fellowship in the Department of Psychiatry at the Yale University School of Medicine and received a B.A. in Psychology from the University of New Haven.
Annie Mitsak, Ph.D.
Co-Founder, President and CEO
Jennifer Good is our co-founder and has served as a member of our board of directors and as our President and Chief Executive Officer since our inception in March 2011. Previously, Ms. Good served at Penwest Pharmaceuticals, where she held various positions including President and Chief Executive Officer, Chief Operating Officer and Chief Financial Officer. Ms. Good currently serves on the board of Rhythm Pharmaceuticals, Inc., a publicly traded rare disease company, and chairs their Compensation Committee. Ms. Good previously served on the board of Juniper Pharmaceuticals, Inc., a publicly traded healthcare company, from September 2017 until it was acquired in August 2018. Ms. Good also serves as a board member of the Friedreich’s Ataxia Research Alliance (FARA), a patient advocacy group advancing treatments for the cure of Friedreich’s Ataxia. Ms. Good is also the Treasurer for a non-profit organization, Newtown Youth and Family Services, which provides mental health services and programs to support the community. Ms. Good received a Bachelor of Business Administration degree with a concentration in accounting from Pacific Lutheran University in 1987 and is a Certified Public Accountant licensed by the State of Washington, although her license is currently inactive.
Chief Financial Officer
Chris Seiter has served as our Chief Financial Officer since May 2018. Prior to joining us, Mr. Seiter served as Chief Financial Officer of Millendo Therapeutics. Previously, Mr. Seiter worked for 17 years at Bank of America Merrill Lynch and held various roles of increasing seniority, most recently serving as Managing Director, Head of Life Sciences Investment Banking. Prior to joining Bank of America Merrill Lynch, Mr. Seiter worked in the healthcare investment banking groups at UBS, Dillon Read and Kidder Peabody. Mr. Seiter also served in the U.S. Navy as a Nuclear Submarine Officer for five years. Mr. Seiter received a B.A. in economics cum laude from the University of Rochester and completed a graduate level program in nuclear engineering at the U.S. Naval Nuclear Power School.
Thomas Sciascia, M.D.
Co-Founder, Chief Medical Officer
Thomas Sciascia, M.D. is our co-founder, and has served as our Chief Medical Officer since our inception in March 2011. Previously, Dr. Sciascia was the Senior Vice President of Clinical Developmentand Regulatory and Chief Medical Officer at Penwest. Prior to joining Penwest, Dr. Sciascia worked at Quintiles, Inc. as a consultant to pharmaceutical and biotechnology companies. Dr. Sciascia also worked as Medical Director at Transkaryotic Therapies, Inc. (later acquired by Shire Pharmaceuticals Group plc). Dr. Sciascia received a B.S. in biology from the Massachusetts Institute of Technology and a medical degree from Columbia University. He is a board-certified neurologist licensed to practice medicine in the state of Massachusetts.
Helena Brett-Smith, M.D.
Chief Development Officer
Dr. Brett-Smith has served as our Chief Development Officer since September 2017. Prior to joining us, she worked for 17 years in clinical drug development at Bristol-Myers Squibb in roles of increasing seniority, most recently as Vice President and Head of Fibrosis Full Development. While at Bristol-Myers Squibb, Dr. Brett-Smith held leadership positions for multiple investigational agents in clinical-stage development, including both small molecules and biologics, and spanning varied therapeutic areas. Dr. Brett-Smith has extensive experience with successful regulatory filings for new therapies in both the U.S. and Europe. Prior to joining Bristol-Myers Squibb, Dr. Brett-Smith was Director of the HIV Program and outpatient care center at the Hospital of Saint Raphael in New Haven, Connecticut. Dr. Brett-Smith earned her undergraduate degree from Yale University and her M.D. from the Stanford University School of Medicine. She completed her residency in Internal Medicine and a fellowship in Infectious Diseases at the Yale School of Medicine.
Chief Commercial Officer and Head of International
Yann Mazabraud has served as our Chief Commercial Officer and Head of International since September 2018, and previously worked as a consultant to us from November 2017 until August 2018. Prior to serving as a consultant to us, Mr. Mazabraud worked at Sanofi Genzyme, serving as U.S. General Manager and North America Head, Rare Diseases. Prior to that, Mr. Mazabraud worked at Sanofi Genzyme Latin America, serving as Vice President and Head, as Central America & Caribbean MCO Regional Director, and as Rare Diseases Business Unit Senior Director. Previously, Mr. Mazabraud held various positions of increasing seniority at Genzyme France from 1999 until 2012. He holds a Masters in Management from Ecole Supérieure de Commerce de La Rochelle.