Trevi Therapeutics reported that the Phase 2b CORAL trial of its oral nalbuphine extended‑release (Haduvio) for chronic cough in idiopathic pulmonary fibrosis (IPF) patients achieved statistically significant reductions in 24‑hour objective cough frequency across all dose groups at week 6. More than 60 % of treated patients achieved at least a 50 % reduction versus baseline, and patient‑reported outcomes mirrored the objective data, confirming a meaningful clinical benefit. Safety data were consistent with the known profile of nalbuphine ER; discontinuation rates due to adverse events were 5.6 % in the combined treatment groups versus 5.0 % in placebo, and serious adverse events were reported in 1.6 % of treated patients compared with 10.0 % in placebo.
The results position Haduvio as a potential first‑in‑class therapy for a severe unmet need, as no FDA‑approved treatments exist for chronic cough in IPF. The dual kappa agonist/mu antagonist mechanism that underpins the drug’s efficacy differentiates it from other neurogenic cough candidates and strengthens Trevi’s competitive moat. Positive data published in a high‑impact journal such as JAMA also de‑risks the development pathway and can accelerate regulatory discussions with the FDA.
Chief Development Officer James Cassella said the publication “validates the trial findings and highlights the significance of chronic cough in patients with IPF.” He added that the statistically significant reduction in cough frequency “shows the potential that nalbuphine ER has for the treatment of chronic cough in patients with IPF” and that the company is “looking forward to continuing the development of nalbuphine ER.” Professor Philip Molyneaux, an investigator on the trial, noted that the consistency between objective and patient‑reported outcomes “demonstrates that the patients are not only experiencing fewer objective coughs, but overall feeling an improvement as well,” reinforcing the need for continued evaluation of the drug.
On the day the results were published, Trevi’s shares rose 5.15 %, reflecting investor enthusiasm for the data. Analysts upgraded price targets and maintained “Strong Buy” ratings, citing the robust efficacy and favorable safety profile as key drivers of the positive market reaction. The positive trial data also bolstered confidence in the company’s strategic plan to pursue regulatory approval for Haduvio in IPF and to expand the program to refractory chronic cough.
The company has scheduled an End‑of‑Phase 2 meeting with the FDA in early 2026 to discuss the chronic cough program for IPF patients, and it plans to initiate a Phase 2b trial for refractory chronic cough in the first half of 2026. These steps signal a clear path toward regulatory submission and potential market entry, while the strong safety profile and high responder rate provide a compelling case for the drug’s commercial viability.
Overall, the publication of the Phase 2b CORAL trial results marks a significant milestone for Trevi Therapeutics, validating the efficacy and safety of Haduvio in a critical patient population and setting the stage for future regulatory and commercial opportunities.
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