Industry Veteran to Lead the Clinical Development of Haduvio™ in Multiple Indications

NEW HAVEN, Conn., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced the appointment of William Forbes, Pharm.D., as Chief Development Officer. Dr. Forbes will join Trevi’s senior management team and be responsible for leading the clinical development of Haduvio which is in late-stage clinical trials in its two lead indications.

“I am happy to welcome Bill to our executive leadership team,” said Jennifer L. Good, President and Chief Executive Officer of Trevi. “Bill has a proven track record of success in developing and managing highly effective product development teams and progressing products through all phases of clinical development and regulatory milestones, including multiple approvals. Bill’s extensive experience in pharmaceutical product development will be extremely valuable as we complete enrollment and report top-line data from our Phase 2b/3 trial for chronic pruritus in patients with prurigo nodularis and our Phase 2 trial for chronic cough in patients with IPF and prepare for the next steps in development for both of these programs.”

Dr. Forbes joins Trevi with over 30 years of experience in pharmaceutical product development. Before joining Trevi, he served as Founder, President and CEO of Vivelix Pharmaceuticals. Prior to Vivelix, Dr. Forbes held multiple senior leadership positions throughout his career, including Chief Development Officer for Salix Pharmaceuticals where he was responsible for the development of Xifaxan (rifaximin) in multiple indications. Dr. Forbes’ contributions at Salix were instrumental in guiding 12 FDA approvals. He holds a Pharm.D. from Creighton University.

“This is an exciting time to join Trevi with two late-stage development programs of Haduvio ongoing which could help to meet the needs’ of patients suffering from serious conditions with no approved therapies,” said Dr. Forbes. “I am impressed with Trevi’s highly skilled professionals and look forward to working with the team to achieve key near-term product development goals this year.”

About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio to treat serious neurologically mediated conditions. Trevi is currently developing Haduvio for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Trevi is currently conducting a Phase 2b/3 clinical trial of Haduvio, referred to as the PRISM trial, in patients with severe pruritus associated with prurigo nodularis and a Phase 2 trial for chronic cough in patients with IPF.

Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

About HADUVIO
Haduvio is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine’s mechanism of action also mitigates the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States and most of Europe. Trevi intends to propose Haduvio as the trade name for the nalbuphine ER investigational product. Haduvio is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.

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 the expected timing of enrollment and for reporting top-line data from, Trevi’s Phase 2b/3 PRISM trial of Haduvio in patients with prurigo nodularis; Trevi’s business plans and objectives, including future plans or expectations for Trevi’s product candidates; 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; uncertainties regarding the scope, timing and severity of the COVID-19 pandemic, the impact of the COVID-19 pandemic on Trevi’s clinical operations and actions taken in response to the pandemic; uncertainties regarding Trevi’s ability to execute on its strategy; the risk that positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; potential regulatory developments in the United States and foreign countries; uncertainties inherent in estimating Trevi’s cash runway, future expenses and other financial results; as well as other risks and uncertainties set forth in the quarterly report on Form 10-Q for the quarter ended June 30, 2020 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.

Investor Contact
Chris Seiter, Chief Financial Officer
Trevi Therapeutics, Inc.
203-304-2499
chris.seiter@trevitherapeutics.com

Media Contact
Rosalia Scampoli
914-815-1465
rscampoli@marketcompr.com