• Margaret Garin, MD, MSCR, joins team to advance the development of Haduvio in chronic cough indications

NEW HAVEN, Conn., April 2, 2024 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced the appointment of Margaret Garin, MD, MSCR, as Vice President of Clinical Development. Dr. Garin will be responsible for progressing the clinical development of Haduvio in chronic cough and brings unique and relevant experience from her previous lead role in clinical development at Bellus Health.

Dr. Garin joins Trevi with over 14 years of industry and academic research experience and has over 9 years of global pharmaceutical industry experience in early and late-stage development. Before joining Trevi, Dr. Garin was accountable for leading the conduct of the successful Phase 2b study and integral to the design and development of the Phase 3 RCC program for Bellus Health (now owned by GSK) as the Executive Director of Clinical Development. Her background spans various stages of the clinical development process including both strategic and executional roles, as well as the science of cough. Prior to her time at Bellus Health, Dr. Garin was the clinical development lead for programs in respiratory and inflammation at Teva Pharmaceuticals. Dr. Garin holds an MD from the Washington University School of Medicine in St. Louis, and a masters in clinical research (MSCR) from the Medical University of South Carolina.

"I am happy to welcome Meg to our team," said David Clark, Chief Medical Officer of Trevi Therapeutics. "Her extensive knowledge and direct therapeutic area experience of successfully managing global clinical trials in refractory chronic cough will be invaluable as we progress Haduvio's development through the current Phase 2a RIVER trial, the Phase 2b CORAL trial, and plan for future development in each indication."

Dr. Garin added, "Having spoken with numerous key opinion leaders in this space, there is an urgent unmet need for new treatment options for chronic cough. I am thrilled to have the ability to continue my work in chronic cough by joining the Trevi team to further the development of Haduvio for these patients."

About Trevi Therapeutics, Inc.

Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC). Trevi is also developing Haduvio for prurigo nodularis. Haduvio is a dual ĸ-opioid receptor agonist and µ-opioid receptor antagonist that works both centrally in the brain as well as peripherally in the lungs and has the potential for a synergistic antitussive effect to treat chronic cough.

The impact of chronic cough is significant and often leads to a decline in patients' social, physical, and psychological quality of life. In IPF, chronic cough may lead to worsening disease and may be associated with a higher risk of progression, death, or need for lung transplant. There are no approved therapies for the treatment of chronic cough in IPF and current treatment options provide minimal relief to patients. RCC affects up to 10% of the adult population, and Haduvio's expansion into RCC has the potential to reach patients suffering from moderate to severe chronic cough. There are also no approved therapies for RCC in the US.

Parenteral nalbuphine is not scheduled by the U.S. Drug Enforcement Agency. Trevi intends to propose Haduvio as the trade name for oral nalbuphine ER. Its safety and efficacy have not been evaluated by any regulatory authority.

For more information, visit www.TreviTherapeutics.com and follow Trevi on X (formerly Twitter) and LinkedIn.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding Trevi's business plans and objectives, including future plans or expectations for Haduvio and plans and timing with respect to clinical trials, expectations regarding Trevi's uses and sufficiency of capital, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost and timing of Trevi's product candidate development activities and ongoing and planned clinical trials; the risk that positive data from a clinical trial may not necessarily be predictive of the results of later clinical trials in the same or a different indication; uncertainties regarding Trevi's ability to execute on its strategy; uncertainties with respect to regulatory authorities' views as to the data from Trevi's clinical trials and next steps in the development path for Haduvio in the United States and foreign countries, including Trevi's ability to submit and get clearance of an IND and other regulatory filings on a timely basis; uncertainties inherent in estimating Trevi's cash runway, future expenses and other financial results, including Trevi's ability to fund future operations, including clinical trials, as well as other risks and uncertainties set forth in the quarterly report on Form 10-k for the quarter and year ended December 31, 2023 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

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