Trevi Therapeutics, Inc. announced the initiation of its Phase 2b CORAL clinical trial evaluating three doses of Haduvio against placebo in approximately 160 IPF patients with chronic cough. This Phase 2b trial builds on the positive results from the Phase 2a CANAL trial, which demonstrated a statistically significant reduction in daytime cough frequency by 75.1%, a 52.5% difference from placebo (p<0.0001). Phase 2b Trial Design: COugh Reduction in IPF with nALbuphine ER (CORAL): The CORAL trial is a double-blind, randomized, placebo-controlled, parallel-arm trial evaluating three doses of Haduvio (27mg, 54mg and 108mg twice daily) against placebo in IPF patients with chronic cough.

Approximately 160 IPF patients with chronic cough are expected to be randomized 1:1:1:1 to one of three Haduvio doses or placebo for a period of 6 weeks, which includes an initial 2-week titration to the target dose followed by 4 weeks of fixed dose administration. The primary efficacy endpoint for the trial is the relative change in 24-hour cough frequency at the end of Week 6 versus baseline for Haduvio compared to placebo, as measured via an objective cough monitor. The trial will also explore secondary endpoints, including patient reported outcome measures for cough, dyspnea, and quality of life.

The protocol for the CORAL trial provides for a sample size re-estimation (SSRE) analysis once approximately 50% of the patients in the trial are evaluable for the primary endpoint. The SSRE is expected to occur in the second half of 2024, and topline data from the full trial are expected to be available in the first half of 2025 assuming there are no adjustments made to the sample size.