On Thursday, Trevi Therapeutics, Inc. (NASDAQ:TRVI) announced the outcome from the planned sample size re-estimation (SSRE) for the ongoing Phase 2b CORAL trial in idiopathic pulmonary fibrosis (IPF) patients with chronic cough, which requires no change to the current sample size for the trial (N=160).
The CORAL trial is a double-blind, randomized, placebo-controlled, parallel-arm trial evaluating three doses of Haduvio (27mg, 54mg, and 108mg twice daily) compared to placebo in IPF patients with chronic cough.
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 with an objective cough monitor (VitaloJAK). The trial will also explore secondary endpoints, including patient-reported outcome measures for cough.
The trial has reached 75% of the targeted enrollment, and topline results from the full trial continue to be expected in the first half of 2025.
The SSRE analysis was conducted on the highest dose (108mg twice daily) in the trial after 50% of the initial targeted trial enrollment, or 80 patients, completed the six weeks of treatment.
Based on the SSRE analysis, it was recommended that the CORAL trial should continue as planned to maintain the pre-specified conditional power of 80% or greater.
The other two potential pre-specified outcomes of the SSRE analysis were increased sample size or futility.
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