Trevi Therapeutics (TRVI) Provides Business Updates

Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for patients with chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced a preview of business updates. Management will be attending the 13^th Annual LifeSci Partners Corporate Access Event in San Francisco from January 8-10 and will be available to discuss updates. This event takes place during the week of the annual J.P. Morgan Health Care Conference.

"Our team is very excited about Trevi's outlook for 2024 having initiated two clinical trials in chronic cough and the Human Abuse Potential study late in 2023," said Jennifer Good, President and CEO of Trevi Therapeutics. "We look forward to advancing the development of Haduvio through both our Phase 2b CORAL dose ranging trial for chronic cough in IPF and our Phase 2a RIVER proof-of-concept trial in refractory chronic cough, as well as completing the Human Abuse Potential study. We believe Haduvio's ability to work both centrally in the brain and peripherally in the lungs has the potential for a synergistic antitussive effect to treat chronic cough that could enable use among patients with both moderate and severe cough frequencies. We look forward to a data-rich year as we progress through this next critical stage of development."

Key Business Updates

• The Phase 2b CORAL trial in IPF patients with chronic cough has regulatory approval in 8 of the 10 expected countries. The trial includes a sample size re-estimation (SSRE) which is expected to occur in the second half of 2024 after approximately 50% of the patients in the trial are evaluable for the primary endpoint. Full enrollment in the trial is expected this year and topline results are expected in the first half of 2025, assuming no adjustments are made to the sample size as a result of the SSRE.
• The Phase 2a RIVER trial in RCC patients has been initiated and the first patient was randomized. Topline data from the trial is expected in the second half of 2024.
• The Human Abuse Potential study is active and dosing is expected to begin in January 2024, with topline data expected in the second half of 2024.

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