TRVI News & Events

Stifel notes Trevi Therapeutics announced the completion of its EOP2 trial with the FDA, securing alignment on the Phase 3 clinical program and remaining Phase1 trials needed to facilitate an NDA for Haduvio in IPF-related chronic cough. The company plans to initiate two pivotal Phase 3 trials in parallel-the first in Q2 and the second in the second half of 2026. Trevi Therapeutics has chosen the initially intended, "safe" path of conducting parallel trials, despite the FDA's guidance of requiring only one pivotal trial, Stifel says, noting that it does not believe this will spare a tremendous amount of time regardless. The firm has a Buy rating on the shares.

Trevi Therapeutics announced the results of its End-of-Phase 2 meeting with the U.S. Food and Drug Administration, FDA. At the meeting, the Company gained overall alignment on the plan for the remaining development program. The Company plans to conduct two pivotal Phase 3 clinical trials and obtained agreement on the remaining Phase 1 clinical studies that the Company expects to conduct to support the New Drug Application, NDA, submission. The Company plans to conduct the Phase 3 trials in parallel with each other and is on track to initiate the first Phase 3 trial in the second quarter of 2026 and the second Phase 3 trial in the second half of 2026.

Trevi Therapeutics announced that the key results from the Phase 2b CORAL trial of oral nalbuphine ER for the treatment of chronic cough in patients with IPF have been published in the Journal of the American Medical Association. "The publication of these positive Phase 2b results with nalbuphine ER in JAMA represents an important validation of the trial findings and highlights the significance of chronic cough in patients with IPF," said James Cassella, CDO. "The statistically-significant reduction in 24-hour objective cough frequency across all dose groups shows the potential that nalbuphine ER has for the treatment of chronic cough in patients with IPF. We look forward to continuing the development of nalbuphine ER, and thank all the patients, investigators, and study staff, who have participated in our clinical trials to get us to this point." The safety results of the CORAL trial were generally consistent with the known safety profile of nalbuphine ER from previous trials. Discontinuation rates due to adverse events were similar in the combined nalbuphine ER dose groups and placebo group. The most common adverse events experienced included: nausea, vomiting, constipation, dizziness, headache, fatigue, somnolence, and dry mouth. Serious adverse events were reported for four patients in the placebo group and for two patients treated with nalbuphine ER.