The stock price of Trevi Therapeutics, Inc. (NASDAQ: TRVI) is increasing significantly on the US stock charts due to positive outcomes from the current Phase 2b CORAL study for patients with idiopathic pulmonary fibrosis (IPF) who have a persistent cough. After a sample size re-estimation (SSRE) investigation revealed positive results, TRVI stock gained traction, rising 17.22% as of the last check, trading at $4.22.
Positive Outcomes from the Sample Size Re-estimation (SSRE)
The SSRE analysis was conducted after 80 patients—50% of the planned enrollment—completed six weeks of treatment. The results indicated that no changes were necessary to the original sample size for the trial, which remains on track to achieve 75% of its target enrollment.
As a result, Trevi Therapeutics expects the trial to continue as planned, maintaining a conditional power of 80% or greater. This outcome reaffirms the robustness of the trial design and the efficacy potential of Haduvio for treating IPF-related chronic cough.
CORAL Trial Overview
The CORAL trial is a double-blind, randomized, placebo-controlled study designed to evaluate the effects of three doses of Haduvio (27mg, 54mg, and 108mg twice daily) on chronic cough in IPF patients.
Trevi Therapeutics will be randomizing approximately 160 participants into one of four groups: three doses of Haduvio or a placebo, with each group undergoing a 6-week treatment period. The trial’s primary efficacy endpoint is the change in 24-hour cough frequency, measured objectively through the VitaloJAK cough monitor. Secondary endpoints will include patient-reported outcomes on cough severity.
Reaffirming the Trial’s Design and Efficacy
The successful SSRE outcome not only supports the trial’s continued progress with the original sample size but also strengthens the efficacy observed in Trevi Therapeutics’ earlier Phase 2a CANAL trial. This milestone underscores TRVI’s confidence in Haduvio’s potential as a first-in-class treatment for IPF chronic cough, a condition that currently lacks approved therapies.
