BPL-003 for Alcohol Use Disorder: Positive Topline Results of Phase 2A Study

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Beckley Psytech today announced positive topline results from their open-label phase 2A study of BPL-003 in participants with moderate-to-severe alcohol use disorder (AUD), which show that treatment with BPL-003 can induce meaningful and sustained reductions in alcohol use and heavy drinking days (HDDs) for up to 3 months following a single dose.¹

“These findings contribute to a growing evidence base demonstrating the potential efficacy of psychedelic-based treatments to address the needs of those living with alcohol use disorder. We have shown that BPL-003 is safe and tolerable, and that a single dose can deliver a rapid and durable effect within a short time in the clinic,” said Rob Conley, MD, Beckley Psytech’s Chief Scientific and Medical Officer. “We now plan to use this data to inform the development of further clinical studies that will investigate BPL-003 as an effective, rapid-acting and accessible treatment option for substance use disorders. I would like to take this opportunity to thank the participants and research teams who have made this study possible.”

BPL-003 is a novel synthetic intranasal formulation of 5-MeO-DMT benzoate and has been specifically designed to deliver rapid and durable efficacy from a single dose and with a short clinic time. This study, conducted at King’s College London and Clerkenwell Health in the UK, evaluated the safety, tolerability, pharmacodynamic effects, and impact of a single dose of BPL-003 on 12 participants with moderate-to-severe AUD when given in combination with relapse prevention cognitive behavioral therapy. The findings show that the mean number of alcohol units per day decreased from 9.3 (12 weeks prior to dosing) to 2.2 (12 weeks post-dosing). The mean percentage of HDDs also dropped from 56% in the pre-dose period to 13% at the end of the study, whilst the mean number of abstinent days increased from 33% to 81%. Importantly, after just 1 dose, 50% of participants remained completely abstinent during the 12-week follow-up period.

BPL-003 was shown to be well-tolerated. Adverse events were reported as mild or moderate, and no serious or severe adverse events were reported. Most patients were assessed as ready for discharge within approximately 2 hours. Clinical data from this study will be shared through publications and conferences in 2025.

“The promising findings from this exploratory study underscore the potential of BPL-003 to provide an effective and durable treatment option for people struggling with alcohol use disorder,” said John Marsden, PhD, PgDip CBT, BABCP, Department of Addictions at the King’s College London. “This is a patient population who tend to face significant challenges in achieving and maintaining abstinence, so it is particularly heartening to see the high rates of abstinence or sustained reductions in alcohol use among the majority of participants in this study. I look forward to exploring these results further in larger studies.”

Beckley Psytech is also exploring BPL-003 as a potential treatment for depression. Initial results from a phase 2A study of BPL-003 for treatment-resistant depression (TRD) showed that a single 10 mg dose of BPL-003 produced a rapid antidepressant response in 55% of patients the day after dosing. Furthermore, this antidepressant effect was durable, with 55% of patients in remission from depression at day 29 and 45% in remission at day 85. Notable was BPL-003’s short treatment duration; acute effects resolved, and patients were deemed ready to be discharged by investigators within an average time of less than 2 hours. Topline data from the global, multi-site phase 2B study of BPL-003 for TRD—the largest ever controlled clinical study of 5-MeO-DMT—are expected in mid-2025.

References

1. Beckley Psytech announces positive topline data from phase IIa study of BPL-003 (intranasal 5-MeO-DMT benzoate) for alcohol use disorder. News release. January 28, 2025. https://www.beckleypsytech.com/posts/beckley-psytech-announces-positive-topline-data-from-phase-iia-study-of-bpl-003-for-alcohol-use-disorder

2. Beckley Psytech announces positive initial data from phase IIa study of novel 5-MeO-DMT formulation BPL-003 for treatment resistant depression. News release. March 27, 2024. Accessed January 28, 2025. https://www.beckleypsytech.com/posts/beckley-psytech-announces-positive-initial-data-from-phase-iia-study-of-bpl-003-for-treatment-resistant-depression