Trevi Therapeutics to Present Ph2a CANAL Trial Data at European Respiratory Society Congress 2024

Trevi Therapeutics, Inc., a biopharmaceutical company in the clinical stage, is developing Haduvio™ (oral nalbuphine ER) as an investigational therapy aimed at treating chronic cough associated with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC). The company has announced that findings from their Phase 2a CANAL trial will be showcased at the European Respiratory Society (ERS) Congress 2024, scheduled in Vienna, Austria from September 7-11. The presentation is set for September 8th.

Professor Jacky Smith, an esteemed Professor of Respiratory Medicine at the University of Manchester and an Honorary Consultant at Manchester University NHS Foundation Trust, will present these findings. Prof. Smith also holds key positions as the Director of the NIHR Manchester Clinical Research Facility, Respiratory Theme Lead at the NIHR Manchester Biomedical Research Centre, and a Senior Investigator at NIHR.

The poster session titled "Research studies in chronic cough" will be held on September 8th from 8:00 a.m. to 9:30 a.m. CET, located at PS-10. The oral presentation is centered on the abstract "Change in objective cough count correlates with improvement in patient-reported outcomes of cough in patients with idiopathic pulmonary fibrosis." Prof. Smith will elucidate the relationship between the objective cough monitor and patient-reported outcomes (PRO) with the use of nalbuphine ER. According to Prof. Smith, PROs are vital qualitative data points in clinical trials as they incorporate the patient's perspective, making this data particularly relevant given the high unmet need for chronic cough treatments in IPF patients.

Trevi Therapeutics focuses on developing Haduvio™, a dual ĸ-opioid receptor agonist and µ-opioid receptor antagonist with extended-release (ER) capabilities. This investigational therapy works both centrally in the brain and peripherally in the lungs, potentially providing a synergistic antitussive effect for chronic cough management. Unlike the parenteral form of nalbuphine, oral nalbuphine ER is not classified by the U.S. Drug Enforcement Agency.

Chronic cough significantly impacts the social, physical, and psychological quality of life for patients and can exacerbate the condition in IPF, potentially leading to disease progression, death, or the need for a lung transplant. As of now, there are no approved therapies for treating chronic cough in IPF, and existing treatment options offer minimal benefit. Chronic cough affects up to 10% of the adult population, and Haduvio's potential expansion into RCC could benefit patients suffering from moderate to severe refractory chronic cough, for which there are also no approved therapies in the U.S.

Trevi Therapeutics plans to market oral nalbuphine ER under the trade name Haduvio, although its safety and efficacy have yet to be evaluated by any regulatory authority.

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