The nonprofit asserted that the trial “should provide a road map for eventual commercialization, and evidence for cost-effective insurance reimbursement.”
B.More Inc., a clinical-stage biopharmaceutical company focused on developing psychedelic medicines for substance-abuse disorders, said its collaborator has been awarded a $3.8 million grant from the National Institute of Alcohol Abuse and Alcoholism.
B.More collaborator and principal investigator Dr. Michael Bogenschutz, who is director of the NYU Langone Center for Psychedelic Medicine, has been leading the nonprofit’s clinical trials for alcohol-use disorder.
According to B.More, the grant will help the nonprofit:
- Elucidate the brain mechanisms of psilocybin-assisted treatment for alcohol-use disorder (AUD)
- Add to the growing body of evidence regarding the safety and efficacy of psilocybin in alcohol-use disorder
- 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, where patients will be recruited and receive residential treatment during the trial.
In support of the research, B.More 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, according to the company.
In a news release, B.More asserted that the trial “should provide a road map for eventual commercialization, and evidence for cost-effective insurance reimbursement.”
“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,” said Carey Turnbull, co-founder and CEO of B.More. “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.”
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-milligram) and inactive placebo, focusing on changes in fMRI metrics, drinking outcomes and self-reported measures of negative emotionality, craving and executive function, according to B.More.
Additionally, the trial will seek to identify neural predictors of successful treatment outcomes, particularly in response to high-dose psilocybin.
In collaboration with Silver Hill Hospital, the trial will randomize 120 participants from the hospital’s 28-day residential treatment program. Primary outcomes will measure changes in neural activation, connectivity and self-reported alcohol use and related psychological measures. Silver Hill Hospital, in New Canaan, Connecticut, is a nationally recognized, not-for-profit hospital for the treatment of psychiatric and addictive disorders, treating more than 3,500 patients annually.
“We are excited to embark on this significant study, which has the potential to help advance the treatment of alcohol-use disorder,” Bogenschutz said. “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.”