Trevi reports success in Phase 2b cough treatment trial

NEW HAVEN, Conn. - Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company with a market capitalization of $662 million, today announced positive results from its Phase 2b CORAL trial, evaluating the investigational therapy Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis (IPF). The trial met its primary endpoint, showing significant reductions in cough frequency across all doses tested. The company’s stock has shown remarkable performance, delivering a 153% return over the past year, though InvestingPro analysis indicates the stock is currently trading above its Fair Value.

Patients in the trial experienced a rapid decrease in cough frequency as early as Week 2, with the most substantial reduction observed in the 108 mg BID dose group, which demonstrated a 43.3% placebo-adjusted change from baseline at Week 6. This group, along with the 54 mg and 27 mg BID dose groups, also saw significant improvements in secondary endpoints such as cough severity and patient-reported outcomes. According to InvestingPro data, five analysts have recently revised their earnings estimates upward for the upcoming period, suggesting growing confidence in the company’s prospects. Subscribers can access 8 additional ProTips and comprehensive financial analysis.

The treatment was generally well-tolerated, with similar discontinuation rates due to adverse events in the Haduvio and placebo groups, at 5.6% and 5.0% respectively. Common adverse events included nausea, vomiting, constipation, dizziness, headache, fatigue, somnolence, and dry mouth, aligning with Haduvio’s known safety profile from previous trials.

The study’s UK Lead Investigator, Professor Philip Molyneaux, highlighted the importance of addressing chronic cough in IPF patients, a condition affecting an estimated 85% of this population and significantly impacting their quality of life. Currently, there are no approved therapies for chronic cough in IPF patients.

Trevi plans to engage with the FDA in an End-of-Phase 2 meeting later this year and aims to initiate a Phase 3 program in the first half of 2026. The positive outcome of the CORAL trial represents a significant step towards providing a treatment option for this unmet medical need. While the company maintains strong liquidity with a current ratio of 15.38 and more cash than debt on its balance sheet, InvestingPro research indicates the company is not expected to be profitable this year. Detailed financial health metrics and comprehensive analysis are available in the Pro Research Report.

The company will further discuss the trial results in a conference call and webcast held today, joined by Professor Molyneaux. Details of the webcast and conference call are available on Trevi Therapeutics’ website.

The information provided is based on a press release statement from Trevi Therapeutics.

In other recent news, Trevi Therapeutics announced positive results from its Phase 2a RIVER trial, assessing the investigational therapy Haduvio for refractory chronic cough (RCC). The trial demonstrated a significant reduction in cough frequency, meeting its primary endpoint with a 67% reduction from baseline. Analysts from H.C. Wainwright initiated coverage with a Buy rating and a $21 price target, citing the promising potential of Haduvio in treating RCC and idiopathic pulmonary fibrosis chronic cough (IPF-CC). Similarly, B.Riley analysts maintained a Buy rating and a $20 target, highlighting the drug’s efficacy and potential for premium pricing. Stifel analysts reiterated their Buy rating with a $15 target, noting the consistency of treatment effects and the study’s high-quality design. Raymond James also maintained a Strong Buy rating, setting a $29 target, and emphasized Haduvio’s robust efficacy signal in RCC. These developments reflect growing confidence in Trevi Therapeutics’ ability to advance Haduvio as a leading treatment for chronic cough conditions.

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