Trevi Therapeutics Updates Haduvio's Clinical Development

Trevi Therapeutics, Inc., a clinical-stage biopharmaceutical firm listed on Nasdaq under the ticker TRVI, is advancing the development of Haduvio™ (oral nalbuphine ER) for chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC). This investigational therapy demonstrates a unique mechanism of action, targeting both central and peripheral aspects of the cough reflex, which could address significant unmet medical needs.

The company announced several key developments in its clinical programs. Jennifer Good, President and CEO of Trevi Therapeutics, remarked on Haduvio's promising potential, especially for chronic cough conditions in IPF, which remain challenging to treat and where existing antifibrotics have shown limited efficacy. Haduvio's dual action mechanism, involving the brain and lungs, could provide a new therapeutic option for patients.

One of the notable updates is the Phase 2b CORAL trial, which targets chronic cough in IPF patients. The trial has reached 50% of its target enrollment, a crucial threshold for the pre-specified sample size re-estimation (SSRE). This re-estimation will occur after the last of these patients completes six weeks of treatment. Depending on SSRE outcomes, which are anticipated by December 2024, the study might maintain its current sample size of 160 participants, increase within a specified range, or be evaluated for futility. If the sample size remains unchanged, topline results are expected in the first half of 2025.

Additionally, the Human Abuse Potential (HAP) study has concluded its dosing phase, with topline results expected in December 2024. This study is pivotal in assessing the abuse potential of Haduvio, ensuring its safe usage profile.

The Phase 2a RIVER trial aimed at treating RCC has also met its planned sample size. However, the trial remains open to enroll additional participants to meet stratification targets. The results from this study are now expected in the first quarter of 2025.

Trevi Therapeutics emphasizes the significant impact of chronic cough on patients' lives, affecting their social, physical, and psychological well-being. In the context of IPF, chronic cough can exacerbate the disease, potentially leading to faster progression, a higher risk of death, or the need for a lung transplant. Currently, there are no approved treatments for chronic cough in IPF, and existing options provide minimal benefit. Chronic cough affects up to 10% of adults, and Haduvio's development for RCC could address a substantial patient population suffering from moderate to severe refractory chronic cough. Notably, there are no approved RCC therapies in the U.S.

Haduvio, an extended-release dual ĸ-opioid receptor agonist and µ-opioid receptor antagonist, is being proposed as the trade name for oral nalbuphine ER. Its potential for delivering a synergistic antitussive effect is under investigation, although its safety and efficacy have not yet been evaluated by any regulatory authority. Trevi Therapeutics continues to focus on advancing Haduvio through its clinical development stages, aiming to bring new hope to patients with chronic cough conditions.