B.More Receives FDA Investigational New Drug Approval for Psilocybin Alcohol Use Disorder Program Phase 2b Clinical Trial
GREENWICH, Conn., Aug 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, announced today that the US Food and Drug Administration has approved its IND application to begin a phase 2 B clinical trial to determine the efficacy and safety of synthetic psilocybin (SYNP-101) in treating patients with alcohol use disorder (AUD). Led by principal investigator, Michael BogenschutzDirector of the NYU Langone Center for Psychedelic Medicine, the trial will be initiated in early 2023.
“Given the amazing results of the psilocybin for AUD Phase 2a trial that our principal investigator, Dr. Bogenschutz, just published in JAMA Psychiatry, we are thrilled to have received FDA approval to begin our phase 2 B trial”, said Carey Turnbull, co-founder and CEO of B.More. “With a reported 83% average reduction in alcohol consumption among heavy drinkers, the results of Dr. Bogenschutz’s recent trial point to the clear potential of psilocybin as a breakthrough in the way we treat AUD.”
B.More’s, randomized, double blind, active placebo-controlled, multicenter, phase 2 B trial will assess the efficacy and safety of synthetic psilocybin (SYNP-101) in treating moderate to severe AUD. The trial plans to enroll a total of 226 participants who will receive psychotherapy and one administration of 30mg of SYNP-101 or the active placebo, niacin. The primary objective of the trial is to determine the efficacy of SYNP-101, compared to niacin, in reducing alcohol consumption during 24-weeks following treatment. Efficacy of treatment will be assessed using changes in alcohol consumption as measured by World Health Organization Risk Drinking Levels Measure of Alcohol Consumption.
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.