Highly experienced clinical drug developer to oversee R&D functions and Companys Phase 3 development program
New Haven, CT, October 12, 2017 – Trevi Therapeutics, Inc. (“Trevi” or the “Company”), a late-stage clinical development company focused on developing Nalbuphine® ER for chronic pruritus (itch), today announced that it has hired Helena Brett-Smith, M.D., as Chief Development Officer.
Dr. Brett-Smith has more than 25 years of clinical and drug development experience. She comes to Trevi from a 17-year career at Bristol-Myers Squibb, where she was most recently Vice President and Head of Fibrosis Full Development. Dr. Brett-Smith has held leadership positions for multiple investigational agents in clinical-stage development. These projects included both small molecules and biologics, and spanned varied therapeutic areas including Virology (HIV, Hepatitis B and Hepatitis C), Immuno-Oncology and Fibrosis. Dr. Brett-Smith has extensive experience with successful regulatory filings for new therapies in both the US and Europe, and with follow-on pediatric indications. She led the global lifecycle development program for BARACLUDE® and has substantial Asian experience, including China, Japan and Korea.
Dr. Brett-Smith earned her undergraduate degree from Yale University and her MD from Stanford University School of Medicine. She completed both a residency in Internal Medicine and a fellowship in Infectious Diseases at the Yale School of Medicine. Prior to joining Bristol-Myers Squibb, she was Director of the HIV Program and Haelen Center at the Hospital of Saint Raphael in New Haven, CT from 1992 to 2000.
Jennifer Good, Trevi’s President and Chief Executive Officer, said, “We are very pleased to add Dr. Brett-Smith’s strong development and regulatory experience to the Trevi team as we continue the development of Nalbuphine ER for chronic pruritus conditions into Phase 3 studies.”
Dr. Brett-Smith added, “I am excited about the significant unmet medical need in pruritus. It is a particular pleasure to join Dr. Sciascia and the strong development team at Trevi, and I look forward to advancing Nalbuphine ER across various itch indications.”
Trevi recently completed a Series C financing of $50.8 million led be New Enterprise Associates, using the proceeds to advance the development of Nalbuphine® ER, a drug with a dual agonist/antagonist mechanism of action uniquely suited to treating itch associated in various dermatologic, metabolic, hematologic, and neuropathic conditions, and also announced positive Phase 2 trial results in reduced itch intensity and other supporting efficacy endpoints in patients with prurigo nodularis, as well as a statistically significant reduction in itch intensity in a Phase 2/3 trial in uremic pruritus.
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a late-stage clinical development company focused on developing Nalbuphine® ER for chronic pruritus (itch). Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing two conditions for clinical development: prurigo nodularis and uremic pruritus. Prurigo nodularis is a chronic pruritic dermatologic condition characterized by the presence of pruriginous lesions (excoriative/ulcerative papules and nodules) on the skin. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with increased mortality. There are no approved therapies in the US or EU for either condition.
Nalbuphine® ER is an oral extended release synthetic opioid with a dual mechanism of action, mu receptor antagonist and kappa receptor agonist, both of which have been shown in research to be effective in abolishing itch. Because of Nalbuphine® ER’s unique dual mechanism of action, which has shown efficacy in addressing pruritus in both animal studies and human clinical trials, the Company believes Nalbuphine ER can have broad utility in treating chronic pruritus.
Founded in 2011, Trevi is headquartered in New Haven, CT.
For additional information, visit www.trevitherapeutics.com.
# # #
Media contact: Laura Brophy, (203) 331-7618, email@example.com