Trevi Therapeutics, Inc. announced the initiation of its Phase 2a RIVER clinical trial evaluating Haduvio in RCC patients. RCC affects up to 10% of adults worldwide and is defined by a cough that lasts >8 weeks and does not respond to therapy for an underlying condition. Topline data from the RIVER trial is expected in the second half of 2024.

Phase 2a Trial Design: Refractory Chronic Cough Improvement Via Nal ER (RIVER): The RIVER trial is a double-blind, randomized, placebo-controlled, 2-period crossover study evaluating the safety and efficacy of Haduvio in reducing chronic cough in RCC subjects. Approximately 60 RCC subjects are expected to be randomized with a 1:1 stratification between those with 10-19 coughs/hour (moderate 24-hour cough frequency) and those with =20 coughs/hour (high 24-hour cough frequency). Each treatment period will last 21 days, separated by a 21-day washout period, and subjects on Haduvio will have the dose titrated from 27 mg once a day (QD) up to 108 mg twice a day (BID) across the 21-day dosing period.

The primary efficacy endpoint for the trial is the relative change in 24-hour cough frequency at Day 21 from treatment period baseline for Haduvio compared to placebo, as measured via an objective cough monitor. The study will also explore secondary endpoints, including patient reported outcome measures for cough and dyspnea.