Trevi Therapeutics reported third-quarter 2026 results alongside progress across clinical programs for Haduvio, its investigational oral treatment for chronic cough. The company has two Phase 3 trials underway in patients with idiopathic pulmonary fibrosis (IPF), and expects to start a Phase 2 study for cough associated with other forms of interstitial lung disease (ILD) in early 2027.
Trevi ended September with $299.4 million in cash, cash equivalents and marketable securities. It said those resources should fund development of Haduvio for IPF-related cough through potential FDA approval, as well as its non-IPF ILD program through Phase 2 and its ongoing trial in refractory chronic cough.
Clinical development
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IPF-related chronic cough: Both Phase 3 OCEAN trials are actively recruiting. OCEAN-2, a 12-week fixed-dose trial launched in the third quarter, is expected to report topline results in the second half of 2027. OCEAN-1, a 52-week fixed-dose trial that began in the second quarter, is expected to report results in the first half of 2028.
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Non-IPF ILD-related chronic cough: Trevi said it reached broad alignment with the FDA on the development path, including the design of a Phase 2 dose-ranging trial. The study is expected to begin in the first quarter of 2027, subject to FDA review of the protocol, and to report topline results in the first half of 2028.
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The planned Phase 2 study is expected to enroll about 120 patients. It will compare two twice-daily doses of nalbuphine ER—54 mg and 27 mg—with placebo. The main measure will be the change from baseline in cough frequency over 24 hours, measured with an objective cough monitor after 12 weeks of fixed dosing.
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Trevi received a notice that a patent application covering nalbuphine ER dosing for patients with impaired liver function and non-IPF ILD-related chronic cough is allowed. If issued, the patent is expected to expire in 2041. Trevi believes it could be listed in the Orange Book for that indication based on the product labeling it currently projects.
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Refractory chronic cough: Enrollment is progressing in the Phase 2b LAKE trial, which began in the second quarter. Trevi expects an interim sample-size assessment, conducted after half the participants complete treatment, to produce an outcome early in the first quarter of 2027. Full-trial topline results remain expected in the second half of 2027.
Financial and operating details
- Research and development expenses were $19.1 million in the third quarter, up from $10.1 million a year earlier. Trevi attributed the increase mainly to clinical work on OCEAN-1, OCEAN-2 and LAKE, as well as higher stock-based compensation and personnel costs. Lower spending on Phase 1 studies supporting a future new drug application and the CORAL trial partly offset the increase.
What changes
Trevi’s development pipeline now includes two active Phase 3 studies for IPF-related cough, an advancing Phase 2b study for refractory chronic cough, and a defined Phase 2 plan for non-IPF ILD-related cough. The company’s stated cash outlook is intended to support these programs on the timelines it outlined, including the IPF program through potential FDA approval.