GREENWICH, Conn., Sept. 12, 2024 /PRNewswire/ — B.More Inc., a 501(c)(3) non-profit, clinical-stage biopharmaceutical company dedicated to the development of psychedelic medicines for substance abuse disorders, proudly announces that its collaborator, Dr. Michael Bogenschutz, Director of the NYU Langone Center for Psychedelic Medicine, has been awarded a $3.8 million grant from the National Institute of Alcohol Abuse and Alcoholism (NIAAA). This significant grant will: (1) elucidate the brain mechanisms of psilocybin-assisted treatment for alcohol use disorder (AUD), (2) add to the growing body of evidence regarding the safety and efficacy of psilocybin in AUD, and (3) begin to answer the question of logistics for provision of care for psilocybin-assisted treatment in real-world treatment settings. The trial will take place in collaboration with Silver Hill Hospital (SSH), where patients will be recruited and receive residential treatment during the trial.

In support of this critical research, B.More Inc. will provide and cover the cost of the cGMP psilocybin to be used in the trial, as well as fund the retention of an independent monitor to ensure high quality data capture acceptable for an eventual New Drug Application (NDA). This trial, in a long-standing substance abuse treatment center, should provide a road map for eventual commercialization, and evidence for cost effective insurance reimbursement. The involvement of NIAAA funding is confirmation of growing interest in the potential of these novel medicines.

According to Carey Turnbull, Co-founder, and CEO of B.More Inc., “The awarding of this NIAAA grant is a significant recognition of Dr. Bogenschutz’s pioneering work in developing new treatment modalities for alcohol use disorder. Building on the groundbreaking results of his well-publicized Phase 2a study on psilocybin for AUD, this trial has the potential to pave the way for more effective treatments for AUD and other substance use disorders, providing new hope for millions struggling with addiction. We are pleased to partner with Dr. Bogenschutz and his team to support this important work.”

The double-blind, randomized, placebo-controlled Phase 2 trial aims to explore the therapeutic neural mechanisms of psilocybin in AUD patients using advanced functional magnetic resonance imaging (fMRI). The study will investigate treatment differences between high-dose (30 mg) and inactive placebo, focusing on changes in fMRI metrics, drinking outcomes, and self-reported measures of negative emotionality, craving, and executive function. Additionally, the trial will seek to identify neural predictors of successful treatment outcomes, particularly in response to high-dose psilocybin.

In collaboration with SHH, the trial will randomize 120 participants from SHH’s 28-day residential treatment program. Primary outcomes will measure changes in neural activation, connectivity, and self-reported alcohol use and related psychological measures. SSH, in New Canaan, Connecticut, is a nationally recognized, not-for-profit hospital for the treatment of psychiatric and addictive disorders, treating over 3,500 patients annually.

‘We are pleased to be a part of this crucial trial advancing the care of individuals with alcohol use disorder,” said Andrew J. Gerber, MD, PhD, President and Medical Director of Silver Hill and site director for this study.

“We are excited to embark on this significant study, which has the potential to help advance the treatment of alcohol use disorder,” said Dr. Michael Bogenschutz. “The generous support from the NIAAA underscores the promise of psilocybin as a transformative therapy for substance abuse disorders. We are committed to advancing our understanding of how psilocybin impacts neural mechanisms and contributes to recovery.”

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.  With researchers at the NYU Grossman 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.

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