trevi therapeutics reports positive results from phase 2b cough trial

Trevi Therapeutics (TRVI) announced positive topline results from its Phase 2b CORAL trial of Haduvio for chronic cough in idiopathic pulmonary fibrosis (IPF) patients, showing statistically significant reductions in 24-hour cough frequency across all dose groups at Week 6; specifically, the 108 mg BID group saw a 60.2% reduction (p<0.0001). The company plans to request an end of Phase 2 meeting with the FDA in the second half of 2025 to discuss a Phase 3 program, and analysts at H.C. Wainwright and B. Riley maintain Buy ratings with price targets of $21 and $20, respectively, citing Haduvio's potential for significant revenue in the refractory chronic cough market.

Analysis

Trevi Therapeutics (NASDAQ:TRVI) reported statistically significant positive topline results from its Phase 2b CORAL clinical trial for Haduvio (oral nalbuphine ER) in treating chronic cough in idiopathic pulmonary fibrosis (IPF) patients. The trial met its primary endpoint, with all dose groups demonstrating notable reductions in 24-hour cough frequency at Week 6: the 108 mg BID dose achieved a 60.2% reduction (p<0.0001), the 54 mg BID dose a 58.9% reduction (p<0.0001), and the 27 mg BID dose a 52.3% reduction (p=0.0004), all compared to a 27.2% reduction in the placebo group. A rapid onset of effect was observed by Week 2, and by Week 6, 60-65% of patients on Haduvio achieved a 50% reduction in cough frequency versus 19% for placebo. Furthermore, the 108 mg BID and 54 mg BID groups showed significant improvements on the cough-severity numerical rating scale (CS-NRS) and the E-RS: IPF Cough Subscale. The safety profile was consistent with prior studies, with discontinuation rates due to adverse events similar between Haduvio (5.6%) and placebo (5.0%). Trevi plans an end-of-Phase 2 meeting with the FDA in H2 2025 to discuss a Phase 3 program and intends to initiate further trials in 2026 for chronic cough in non-IPF interstitial lung disease and refractory chronic cough. Despite the stock's impressive 153% return over the past year and a market capitalization of $743 million, InvestingPro analysis suggests it is overvalued, though analyst price targets range from $11 to $29. Notably, H.C. Wainwright (Buy, $21 PT) estimates Haduvio's potential revenue in the refractory chronic cough market could exceed $1 billion, while B.Riley (Buy, $20 PT) and Stifel (Buy, $15 PT) also maintain positive outlooks. The stock exhibits lower volatility with a beta of 0.62 and five analysts have recently upwardly revised earnings estimates, reflecting strong sentiment around these trial results.

Key Decisions for Investors

• Consider the strong positive Phase 2b trial results and supportive analyst ratings as significant de-risking events for Haduvio's clinical development path, particularly given the high unmet need in IPF-related chronic cough.
• Evaluate the current valuation carefully, as InvestingPro suggests the stock is overvalued despite the positive news, weighing the 153% year-over-year gain against future milestones such as the FDA meeting in H2 2025 and initiation of further trials in 2026.
• Monitor upcoming catalysts, including the end-of-Phase 2 meeting with the FDA and progress towards the Phase 3 program, as well as data from planned trials in other chronic cough indications, which could further validate Haduvio's market potential.
• Given the lower beta of 0.62, investors seeking exposure to the biotech sector with potentially lower relative volatility might find TRVI appealing, but should remain cognizant of the timelines involved in drug development and regulatory approval processes.