Trevi Therapeutics Completes Enrollment for Phase 2b CORAL Trial of Haduvio in Idiopathic Pulmonary Fibrosis Patients with Chronic Cough

Core Insights - Trevi Therapeutics has completed enrollment in its Phase 2b CORAL trial for Haduvio, targeting chronic cough in patients with idiopathic pulmonary fibrosis (IPF), with topline results expected in the first half of 2025 [1][2] Company Overview - Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing Haduvio (oral nalbuphine ER) for chronic cough in IPF and refractory chronic cough (RCC) [5] - Haduvio functions as a kappa agonist and mu antagonist, acting on the cough reflex arc to manage cough hypersensitivity [5] Clinical Trial Details - The CORAL trial is a double-blind, randomized, placebo-controlled study evaluating three doses of Haduvio (27mg, 54mg, and 108mg) against placebo over a 6-week period, involving approximately 160 IPF patients [3] - The primary efficacy endpoint is the relative change in 24-hour cough frequency at the end of Week 6 compared to baseline, measured with an objective cough monitor [3] Market Need - Chronic cough affects up to 85% of the IPF population, with around 140,000 IPF patients in the U.S., leading to significant health impacts and a high frequency of coughing [4] - There are currently no approved therapies for chronic cough in IPF patients, highlighting a substantial unmet medical need [4] Refractory Chronic Cough Context - Refractory chronic cough impacts approximately 2-3 million adults in the U.S., causing various complications and significant social and economic burdens [6]