OXFORD, UNITED KINGDOM - 28 JANUARY 2025. Beckley Psytech Ltd, the private, clinical-stage biopharmaceutical company developing effective, rapid-acting and accessible medicines for mental health conditions, today announced positive topline findings from their open-label Phase IIa study of BPL-003 in patients with moderate-to-severe Alcohol Use Disorder (AUD). The results 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.
The goals of this study, which took place at King’s College London and Clerkenwell Health in the UK, were to evaluate the safety, tolerability, pharmacodynamic effects and impact on alcohol use of a single dose of BPL-003 - when given in combination with relapse prevention cognitive behavioural therapy - in 12 patients diagnosed with moderate-to-severe AUD. The findings show that the mean number of alcohol units per day decreased from 9.3 in the 12 weeks prior to dosing to 2.2 at 12 weeks post-dosing. The mean percentage of Heavy Drinking Days 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%. Furthermore, 50% of participants remained completely abstinent during the 12-week follow-up period following a single dose.
BPL-003 was shown to be well-tolerated with adverse events (AEs) being reported as mild or moderate and there were no serious or severe adverse events reported. Most patients were also assessed as ready for discharge within approximately 2 hours. More detailed clinical data from this AUD study will be shared through publications and conferences in 2025.
Commenting on the Phase IIa results, Professor John Marsden, Department of Addictions, King’s College London, said: “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. 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."
Dr Rob Conley, Beckley Psytech’s Chief Scientific and Medical Officer, also said: “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. 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.”
AUD is a medical condition characterised by an impaired ability to stop or control alcohol use despite adverse social, occupational, or health consequences. The World Health Organisation estimates that around 400 million people suffer with AUD worldwide, with around 3 million deaths each year attributed to the harmful use of alcohol. Currently available pharmacological treatment options are not very effective and some people with alcohol use disorder who wish to abstain from, or reduce, alcohol consumption do not achieve their treatment goal with currently approved treatment options. This contributes to an unmet need for more effective medical treatments.
BPL-003 is Beckley Psytech’s 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 time in clinic. Alongside these investigations into BPL-003 as a treatment for Alcohol Use Disorder, Beckley Psytech is also exploring BPL-003 as a potential intervention for depression. Initial results from a Phase IIa study of BPL-003 for Treatment Resistant Depression (TRD) showed that a single 10mg dose of BPL-003 produced a rapid antidepressant response in 55% of patients the day after dosing and this antidepressant effect was durable, with 55% of patients in remission from depression at day 29 and 45% in remission at day 85. BPL-003 also demonstrated a short treatment duration, with acute effects resolving and patients deemed ready to be discharged by Investigators within an average time of less than 2 hours. Topline data from Beckley Psytech’s global, multi-site Phase IIb study of BPL-003 for TRD are expected in mid-2025. That study is thought to be the largest ever controlled clinical study to investigate 5-MeO-DMT.
For more information please contact: Charlotte Chorley, Communications Lead, at info@beckleypsytech.com
About Beckley Psytech - www.beckleypsytech.com
Beckley Psytech Ltd is a private, clinical-stage biopharmaceutical company dedicated to improving the lives of people living with neuropsychiatric disorders by developing effective and rapid-acting psychedelic medicines. Founded in 2019, and underpinned by more than two decades of pioneering scientific research from the Beckley Foundation, Beckley Psytech combines world-leading psychedelic science with extensive drug development expertise in order to optimise patient outcomes, improve treatment opportunities and ease the burden neuropsychiatric conditions have on individuals, healthcare systems and society. The company’s lead compound, BPL-003, is a novel, synthetic 5-MeO-DMT benzoate salt formulation currently under investigation in Phase II studies as a potential therapy for depression and Alcohol Use Disorder. BPL-003 is covered by granted US, UK and European composition of matter patents, with multiple further claims pending in various jurisdictions. Beckley Psytech’s second clinical-stage asset, ELE-101, is a proprietary intravenous formulation of psilocin currently being developed as a potential treatment for Major Depressive Disorder.
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