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Trevi Therapeutics, Inc. (NASDAQ:TRVI) announced today that its Phase 2a RIVER trial of Haduvio for refractory chronic cough (RCC) yielded positive results. The trial met its primary endpoint, showing a significant reduction in 24-hour cough frequency by 67% from baseline, and 57% when adjusted for placebo (p
The trial, which was randomized, double-blind, placebo-controlled, and featured a crossover design, aimed to assess the efficacy, safety, and tolerability of Haduvio in RCC treatment. It involved 66 patients over two 21-day treatment periods, separated by a 21-day washout. The primary endpoint was based on the mean change in 24-hour cough frequency at Day 21, with the full analysis set population including 59 patients. According to InvestingPro data, Trevi maintains a strong liquidity position with a current ratio of 7.38, indicating robust financial flexibility to support its clinical programs.
Haduvio also demonstrated significant reductions in cough frequency in the severe and moderate cough subgroups, with 84% of patients experiencing at least a 30% reduction in cough frequency compared to 29% of those on placebo. Additionally, significant improvements in patient-reported outcomes were noted as early as Day 7 of the trial.
The safety profile of Haduvio was consistent with previous trials, with the most common adverse events being constipation, nausea, somnolence, headache, dizziness, and fatigue. No treatment emergent serious adverse events were reported.
Following these results, Trevi plans to engage with the FDA to discuss next steps and anticipates initiating a subsequent study after receiving FDA input.
This news is based on a press release statement and the company’s forward-looking statements are subject to risks and uncertainties, with actual results potentially differing materially. The company has no obligation to update these statements post-publication.
In other recent news, Trevi Therapeutics announced positive results from its Phase 2a RIVER trial for its drug Haduvio, which is being developed to treat refractory chronic cough (RCC). The trial demonstrated a 57% placebo-adjusted reduction in cough frequency, significantly surpassing the original goal and outperforming similar treatments. Analysts have responded favorably, with Raymond (NSE:RYMD) James upgrading Trevi to a Strong Buy and raising the price target to $29.00, while Needham increased its target to $25.00. Rodman & Renshaw also raised their price target to $20.00, and Leerink Partners adjusted their target to $11.00, all maintaining positive ratings on the stock. These revisions reflect confidence in Haduvio’s market potential, especially given its unique dual mechanism of action and its success in both RCC and idiopathic pulmonary fibrosis-related chronic cough (IPF-CC). The promising trial results have positioned Trevi Therapeutics as a potential leader in the RCC treatment landscape, with analysts at Stifel maintaining a Buy rating and a $12.00 target. The absence of FDA-approved treatments for RCC further highlights the significance of these developments for Trevi. As the company prepares for a Phase 2b readout in IPF-CC in 2025, the recent data has reduced the perceived risk for future trials.
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