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Trevi Therapeutics Completes Enrollment for Phase 2b CORAL Trial of Haduvio in Idiopathic Pulmonary Fibrosis Patients with Chronic Cough
Topline results continue to be expected in the first half of 2025 NEW HAVEN, Conn., Feb. 25, 2025 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a
About this update from Trevi Therapeutics, Inc.
[{"type":"text","content":"Topline results continue to be expected in the first half of 2025\nNEW HAVEN, Conn., Feb. 25, 2025 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced that it has completed enrollment in its Phase 2b CORAL trial of Haduvio for the treatment of chronic cough in patients with IPF. Topline results continue to be expected in the first half of 2025.\n\n \n \n \n \n \n \n\n \n\"The completion of enrollment in the Phase 2b CORAL trial is a significant milestone in the development of Haduvio for patients with idiopathic pulmonary fibrosis suffering from chronic cough,\" said James Cassella, Chief Development Officer of Trevi Therapeutics. \"Chronic cough has a significant impact on IPF patients, and its persistent physical effects may worsen a patient's overall health. Current off-label treatments and antifibrotics are often ineffective against chronic cough, leaving a substantial unmet need. The results from this study will help us determine the optimal doses of Haduvio to move into our pivotal Phase 3 program. We look forward to reporting topline data in the first half of this year.\"\nPhase 2b IPF Chronic Cough Trial Design (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) compared to placebo in IPF patients with chronic cough over a 6-week period. Approximately 160 IPF patients with chronic cough were randomized 1:1:1:1 to one of three Haduvio doses or placebo with an initial 2-week titration period to the target dose followed by 4 weeks of fixed dosing. 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. The trial will also explore secondary endpoints, including patient reported outcome measures for cough.\nAbout Idiopathic Pulmonary Fibrosis Chronic CoughChronic cough is highly prevalent in IPF patients, impacting up to 85% of the IPF population. There are ~140,000 U.S. IPF patients and the impact of chronic coug...