Beckley Psytech has initiated a Phase IIa study of its 5-MeO-DMT candidate – BPL-003 – for Alcohol Use Disorder (AUD), which will take place at King’s College Hospital in London.
Despite Alcohol use disorders estimating to affect around 237 million people across the globe, and with three million deaths each year attributed to the harmful use of alcohol, there is still a lack of effective treatment options.
Relapse rates for alcohol use disorder are also high following treatment.
Beckley Psytech’s open-label study, which has been developed in collaboration with Professor John Marsden, an addiction expert psychologist from the NIHR Maudsley Biomedical Research Centre at King’s College London, will investigate the safety, efficacy and pharmacokinetics of BPL-003 in AUD patients.
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 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.
Cosmo Feilding Mellen, CEO of Beckley Psytech, stated: “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.”
In the study, 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.
