The article Beckley Psytech Launches Phase 2a study of 5-MeO-DMT for Alcohol Use Disorder was originally published on Microdose.

Beckley Psytech is moving its 5-MeO-DMT program forward, announcing a new Phase IIa study investigating its lead candidate, BPL-003, as a potential treatment for alcohol use disorder (AUD).

BPL-003 is Beckley Psytech’s novel synthetic formulation of the psychedelic compound 5-MeO-DMT, administered intranasally via an FDA-approved delivery device.

Beckley Psytech’s Phase IIa study, taking place at King’s College Hospital in London, will explore the safety, efficacy and pharmacokinetics of BPL-003 in patients diagnosed with alcohol use disorder (AUD).

See the full press release below.

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Beckley Psytech initiates Phase IIa study of 5-MeO-DMT candidate BPL-003 for Alcohol Use Disorder

• Open-label study will investigate the safety, efficacy and pharmacokinetics of BPL-003 in patients diagnosed with alcohol use disorder (AUD).
• BPL-003 is Beckley Psytech’s patent-protected benzoate formulation of 5-MeO-DMT (Mebufotenin) and is administered intranasally via an FDA-approved delivery device.
• The first participant in the study, which is taking place at King’s College Hospital in London, is expected to be treated in April 2023, with preliminary results anticipated in Q3 2023.

Oxford, United Kingdom – 05 APRIL 2023 – Beckley Psytech Ltd, a private, clinical-stage biotechnology company dedicated to addressing neuropsychiatric disorders by transforming psychedelics into effective and licensed medicines, today announced that it has initiated a Phase IIa study (NCT05674929) investigating its lead candidate, BPL-003, as a potential treatment for alcohol use disorder (AUD).

BPL-003 is Beckley Psytech’s novel synthetic formulation of the psychedelic compound 5-MeO-DMT (also known as Mebufotenin) and is administered intranasally via an FDA-approved delivery device. Phase I data has already shown BPL-003 to be well-tolerated with consistent dose delivery, a reproducible and dose-linear pharmacokinetic profile, and a reliable induction of profound psychedelic experiences. Beckley Psytech’s Phase IIa study, taking place at King’s College Hospital in London, will explore the safety, efficacy and pharmacokinetics of BPL-003 in patients diagnosed with alcohol use disorder (AUD).

Alcohol use disorders are estimated to affect around 237 million people across the globe, with 3 million deaths each year attributed to the harmful use of alcohol. Despite this, there is a lack of effective treatment options and relapse rates are high.

In the open-label study, which was developed in collaboration with Professor John Marsden, an addiction expert psychologist from the NIHR Maudsley Biomedical Research Centre at King’s College London, patients with AUD will be given a single dose of BPL-003 alongside an abstinence-oriented cognitive behavioural psychological intervention. Patients will then be followed for 12 weeks after initial dosing, with safety, pharmacokinetic and efficacy assessments conducted at multiple points throughout that period.

Enrollment into the trial will be commencing soon, with the first patient expected to be treated in April 2023. Preliminary results are anticipated later in 2023 and will be used alongside results from Beckley Psytech’s other Phase IIa study of BPL-003 for treatment resistant depression (TRD) to inform the future development programme for BPL-003.

Cosmo Feilding Mellen, CEO of Beckley Psytech, said: “There is increasing evidence demonstrating the therapeutic effect of psychedelics for substance use disorders. We are proud to be at the forefront of this field of research, exploring how short-acting formulations like BPL-003 might address and reduce the burden that conditions like alcohol use disorder have on individuals, society and healthcare systems more broadly. We are committed to the rigorous scientific investigation of these compounds, and we look forward to enrolling the first patient in this study in the coming weeks.”

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