Shares of Trevi Therapeutics, Inc. (NASDAQ:TRVI) surged 32% following the announcement of positive topline results from their Phase 2a RIVER trial of Haduvio. The clinical-stage biopharmaceutical company reported that Haduvio met its primary endpoint, showing a significant reduction in chronic cough frequency among patients with refractory chronic cough (RCC) and idiopathic pulmonary fibrosis (IPF).
The RIVER trial, which tested the efficacy, safety, and tolerability of Haduvio in RCC patients, demonstrated a 67% reduction in 24-hour cough frequency from baseline and a 57% reduction on a placebo-adjusted basis. These results were bolstered by significant improvements in both patient-reported outcomes and other secondary endpoints. Notably, Haduvio is the first therapy to show a statistically significant reduction in chronic cough across both RCC and IPF patient groups.
The RIVER trial’s design was a randomized, double-blind, placebo-controlled, crossover study, which included titration assessments of Haduvio at multiple dosages. The primary endpoint focused on the mean change in 24-hour cough frequency, with the Haduvio group achieving a 67% reduction compared to a 10% reduction in the placebo group.
In addition to the primary endpoint, Haduvio showed a 66% reduction in 24-hour cough frequency in the severe cough subgroup and a 55% difference in the proportion of patients achieving at least a 30% reduction in 24-hour cough frequency compared to placebo. Improvements were observed as early as Day 7 of the trial, and the safety results were generally consistent with the known safety profile of Haduvio.
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