Trevi Therapeutics, Inc. (Nasdaq: TRVI) has reported key milestones in its clinical development programs for Haduvio™ (oral nalbuphine ER), an investigational therapy targeting chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC). The company anticipates a data-rich period with results expected from multiple trials in the coming months.
CORAL Trial Progress
The Phase 2b CORAL trial, evaluating Haduvio for chronic cough in IPF patients, has reached 50% of its targeted enrollment. This milestone triggers a pre-specified sample size re-estimation (SSRE) to be conducted after the last of these patients completes six weeks of treatment. The SSRE outcome, expected in December 2024, will determine whether the trial maintains its current sample size (N=160), increases it within a pre-specified range, or is evaluated for futility. Assuming no sample size adjustments, topline results are anticipated in the first half of 2025.
Human Abuse Potential Study Completed
Trevi Therapeutics has completed dosing in its Human Abuse Potential (HAP) study for Haduvio. Topline results from this study are also expected in December 2024. This study is crucial for understanding the safety profile of Haduvio, an important consideration for a drug with opioid receptor activity.
RIVER Trial Enrollment Update
The Phase 2a RIVER trial, which is investigating Haduvio for the treatment of RCC, has reached its planned sample size. However, enrollment remains open to better align with stratification targets. Topline results for the RIVER trial are now expected in the first quarter of 2025.
Haduvio's Potential Impact
Jennifer Good, President and CEO of Trevi Therapeutics, emphasized the significance of these milestones, noting that chronic cough in IPF is a particularly challenging condition to treat. Current antifibrotic therapies have not demonstrated a benefit for this symptom. Haduvio's dual mechanism of action, acting both centrally in the brain and peripherally in the lungs, positions it uniquely to address the cough reflex arc and potentially provide relief for IPF patients.
Chronic cough affects up to 10% of the adult population and can significantly impair patients' quality of life. In IPF, chronic cough is associated with disease progression, increased mortality risk, and the need for lung transplantation. There are currently no approved therapies for chronic cough in IPF, highlighting the unmet medical need that Haduvio aims to address. Similarly, there are no approved therapies for RCC in the U.S., representing another significant market opportunity for Trevi Therapeutics.
About Haduvio
Haduvio (oral nalbuphine ER) is an extended-release formulation of nalbuphine, a dual κ-opioid receptor agonist and μ-opioid receptor antagonist. This mechanism of action allows Haduvio to work both centrally and peripherally to suppress cough. Parenteral nalbuphine is not scheduled by the U.S. Drug Enforcement Agency.
