A Chronic Cough Pipeline in a Product: Haduvio™

INDICATIONS

Preclinical

Phase 1

Phase 2

Phase 3

Haduvio (nalbuphine ER)

Preclinical

Phase 1

Phase 2

Phase 3

Chronic Cough in Idiopathic Pulmonary Fibrosis (IPF)

  • 70% 70%

Refractory Chronic Cough (RCC)

  • 60% 60%

Supportive Clinical Studies:

• Ph1 Respiratory Physiology Study in IPF

• Human Abuse Potential (HAP) Study

Supportive Clinical Studies:

• Ph1 Respiratory Physiology Study in IPF
• Human Abuse Potential (HAP) Study

Haduvio™ (oral nalbuphine ER) is a centrally and peripherally acting investigational therapy which we are currently developing for the treatment of patients with serious chronic cough conditions including idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC).

“You’re just coughing and coughing and coughing and you get all heated up, lightheaded, feel like you want to pass out because the severity of the cough has taken so much out of you”

– Chronic Cough Patient

Kum E et al. 2022 doi: 10.1183/23120541.00667-2021

“You’re just coughing and coughing and coughing and you get all heated up, lightheaded, feel like you want to pass out because the severity of the cough has taken so much out of you”

– Chronic Cough Patient

Kum E et al. 2022 doi: 10.1183/23120541.00667-2021

Chronic Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF)

IPF is a serious, end-of-life disease. There are estimated to be 140,000 IPF patients in the US and more than 1 million patients ex-US. Up to 85% of these patients experience chronic cough. The exact cause of chronic cough in IPF patients is thought to be a result of increased sensitivity to cough stimuli. The cough in IPF may be an early clinical marker of disease activity that could potentially help to identify patients at high risk of progression and predict time to death or lung transplant.

Patients with chronic cough in IPF can cough up to 1,500 times per day, leading to increased feelings of fear, stress, fatigue, an urge to breathe, low levels of oxygen in blood, and some patients experience loss of bladder control. The social impact of chronic cough in IPF is increased because of limited exercise ability, reduced walking distance, and the need to use additional oxygen. In addition to the social and physical impact of cough, the repetitive coughing may also contribute to worse health outcomes such as respiratory hospitalizations, mortality, or time to transplant. There are no approved therapies for the treatment of chronic cough in IPF and it is often unaffected by antitussive therapy.

Refractory Chronic Cough (RCC)

Chronic cough affects up to 10% of the adult population and is defined as a persistent cough lasting >8 weeks, despite treatment for an underlying condition OR where no cough associated conditions can be identified (UCC). RCC is caused by cough reflex hypersensitivity in the central and peripheral nerves. It is highly disruptive and accompanied by a wide range of complications, ranging from urinary incontinence in females to sleep disruption and social embarrassment that causes significant social and economic burden for patients and those around them.

RCC Cough Frequency

LifeSci Capital Report Nov 2022, US (N=1000)

Cough frequency can vary from patient to patient. 73% of RCC patients report a moderate to high frequency of daily coughs and in 72% of those patients the cough is uncontrolled leaving a large unmet need.

The most common causes of RCC are asthma, gastroesophageal reflux disease (GERD), non-asthmatic eosinophilic bronchitis, and upper airway cough syndrome or post-nasal drip. There are no approved therapies for RCC in the U.S. or U.K.