Trevi Expects Q1 2027 Start for Phase 2 Non-IPF ILD-Related Chronic Cough Trial

Trevi Therapeutics expects a Phase 2 trial to start in Q1 2027 for cough linked to interstitial lung disease other than idiopathic pulmonary fibrosis, pending protocol review by the U.S. Food and Drug Administration (FDA).

The study will compare two doses of extended-release nalbuphine with a placebo in about 120 patients. Trevi expects top-line results in the first half of 2028.

Trevi reached overall alignment with the FDA on the development path, including the trial design, at an October meeting.

The company ended the third quarter with $299.4 million in cash, cash equivalents and marketable securities. It expects those resources to support Haduvio development for IPF-related chronic cough through potential FDA approval, the non-IPF ILD program through Phase 2 and its ongoing Phase 2b trial for refractory chronic cough. Trevi expects its cash runway to extend into 2030.