Investing.com -- 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.

Jennifer Good, President and CEO of Trevi Therapeutics, expressed optimism about the trial’s outcomes, highlighting the quick and effective response of Haduvio at the lowest dose tested across various cough counts. The company’s Chief Development Officer, James Cassella, Ph.D., echoed this sentiment, emphasizing the consistent outcomes across primary and analyzed secondary endpoints.

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.

Trevi Therapeutics plans to discuss the next steps with the FDA and anticipates initiating the next study after receiving the agency’s input. The positive trial results have clearly resonated with investors, as evidenced by the significant uptick in the company’s stock price.

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