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Trevi Therapeutics Announces the Initiation of its Phase 2a RIVER Clinical Trial of Haduvio™ for Refractory Chronic Cough
Expect to enroll 60 subjects across a broad range of cough frequencies RIVER topline data expected in the second half of 2024 NEW HAVEN, Conn., Nov. 2, 2023
About this update from Trevi Therapeutics, Inc.
[{"type":"text","content":"Expect to enroll 60 subjects across a broad range of cough frequencies\nRIVER topline data expected in the second half of 2024\nNEW HAVEN, Conn., Nov. 2, 2023 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for difficult to treat patients with chronic cough in idiopathic pulmonary fibrosis (IPF), refractory chronic cough (RCC), and prurigo nodularis, today announced the initiation of its Phase 2a RIVER clinical trial evaluating Haduvio in RCC patients. RCC affects up to 10% of adults worldwide and is defined by a cough that lasts >8 weeks and does not respond to therapy for an underlying condition. Topline data from the RIVER trial is expected in the second half of 2024.\n\n \n \n \n \n \n \n\n \n\"We are excited about the initiation of the RIVER study in refractory chronic cough,\" said Jennifer Good, President and CEO of Trevi Therapeutics. \"Based on our positive data in IPF chronic cough, we believe Haduvio has the potential to provide therapy for severe cough across a broad range of cough frequencies through its differentiated central and peripheral mechanism of action. The RIVER study will not only enroll severe RCC subjects in the high cough frequency population, but also subjects with a moderate cough frequency, where a significant unmet need still exists.\"\nPhase 2a Trial Design: Refractory Chronic Cough Improvement Via Nal ER (RIVER)The RIVER trial is a double-blind, randomized, placebo-controlled, 2-period crossover study evaluating the safety and efficacy of Haduvio in reducing chronic cough in RCC subjects. Approximately 60 RCC subjects are expected to be randomized with a 1:1 stratification between those with 10-19 coughs/hour (moderate 24-hour cough frequency) and those with ≥20 coughs/hour (high 24-hour cough frequency). Each treatment period will last 21 days, separated by a 21-day washout period, and subjects on Haduvio will have the dose titrated from 27 mg once a day (QD) up to 108 mg twice a day (BID) across the 21-day dosing period.\nThe primary efficacy endpoint for the trial is the relative change in 24-hour cough frequency at Day 21 from treatment period baseline for Haduvio compared to placebo, as measured via an objective cough monitor. The study will also explore secondary endpoint...