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

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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.

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