Phase IIa study will investigate psychedelic for alcohol use disorder

Woman with alcohol use disorder

Beckley Psytech has initiated a 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 (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 AUD.

The open-label study was developed in collaboration with Professor John Marsden, an addiction expert psychologist from the NIHR Maudsley Biomedical Research Centre at King’s College London.

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.”

Alcohol use disorders are estimated to affect around 237 million people across the globe, with three 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.

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