Trevi Therapeutics Announces Positive Topline Results from the Phase 2b CORAL Trial of Haduvio in Patients with Idiopathic Pulmonary Fibrosis Chronic Cough

Core Insights - Trevi Therapeutics announced positive topline results from its Phase 2b CORAL trial for Haduvio, demonstrating significant reductions in 24-hour cough frequency in patients with idiopathic pulmonary fibrosis (IPF) [1][2][9] Trial Results - The primary endpoint was achieved with Haduvio showing statistically significant reductions in cough frequency: 60.2% for 108 mg BID, 53.4% for 54 mg BID, and 47.9% for 27 mg BID, compared to a 16.9% reduction in the placebo group [1][3][9] - A rapid reduction in cough frequency was observed at Week 2, with 65% of patients on 108 mg BID achieving a 50% reduction by Week 6 [11] - Discontinuation rates due to adverse events were similar between Haduvio (5.6%) and placebo (5.0%) groups, indicating a favorable safety profile [6][9] Future Plans - Trevi plans to request an End-of-Phase 2 meeting with the FDA and initiate the Phase 3 program in the first half of 2026 [1][7] - The CORAL trial is a significant milestone as it is the first positive Phase 2b study for chronic cough in IPF patients, addressing an unmet medical need [2][9] Background on IPF and Chronic Cough - Chronic cough affects approximately 85% of IPF patients, with around 140,000 patients in the U.S. suffering from IPF [10][12] - There are currently no approved therapies for chronic cough in this population, highlighting the importance of Haduvio's development [12][13]