B.More Submits FDA Investigational New Drug Application for Psilocybin Alcohol Use Disorder Program

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Jul 25, 2022, 10:00 ET

GREENWICH, Conn., July 25, 2022 /PRNewswire/ -- B.More Inc., a 501(c)(3) non-profit, clinical-stage biopharmaceutical company focused on the development of psychedelic medicines for substance abuse disorders, today announced the submission of an IND application to begin a Phase 2b trial to determine the efficacy and safety of synthetic psilocybin (SYNP-101) in treating alcohol use disorder (AUD). The trial, which will be initiated in early 2023, will be led by principal investigator Michael Bogenschutz, Director of the NYU Langone Center for Psychedelic Medicine.

According to Carey Turnbull, Co-founder and CEO of B.More, "B.More's psilocybin AUD program IND application is a major step forward in our mission to develop psychedelic medicines for individual struggling with alcohol use disorder. Our Phase 2b trial builds on the impressive work led by Dr. Bogenschutz and will provide vital data to further advance our drug development program."

B.More's Phase 2b, multicenter, randomized, double blind, active placebo controlled clinical trial will assess the 24-week efficacy and safety of synthetic psilocybin (SYNP-101) in treating moderate to severe alcohol use disorder (AUD). With a planned 226 participants, it will be the second largest psychedelics clinical trial ever conducted.

According to the US Centers for Disease Control and Prevention, excessive alcohol use kills roughly 95,000 Americans each year and is the leading cause of preventable death. In addition to increased risk of chronic disease and death, excessive alcohol use can negatively impact memory, learning and mental health and carries massive economic and social costs.

About B.More

Founded in 2017 by Carey and Claudia Turnbull, B.More is a 501(c)(3) non-profit, clinical-stage biopharmaceutical company with a mission to develop better treatment options for those struggling with alcohol use disorder and other substance use disorders. Named after Claudia Turnbull's brother, Brett Moore, who died of a drug overdose 50 years ago, B.More is focused on the development and commercialization of psychedelic medicines that offer the potential to dramatically improve the lives of those for whom current treatment options have not proved effective. Based on a long history of partnership with researchers at the NYU School of Medicine, B.More is advancing clinical research to help these individuals and their loved ones live a better tomorrow.

For more information, please visit www.bmoreinc.org

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SOURCE B.More Inc.