The first participant is expected to be enrolled in April 2023 and initial results should be made available in Q3 of 2023.
Beckley Psytech has just announced the start of the Phase IIa clinical trial of BPL-003, a unique formulation of 5-MeO-DMT (Mebufotenin), for treating alcohol use disorder. This open-label study will take place at King's College Hospital in London and will evaluate the safety, efficacy and pharmacokinetics of BPL-003 when administered intranasally via an FDA approved delivery device. The company anticipates treating their first participant in April 2023 and having preliminary results ready by Q3 of the same year.
Last year, BPL-003 underwent its Phase I clinical study and was then developed as a potential treatment for both treatment resistant depression and alcohol use disorder.
To assess safety, tolerability and pharmacokinetics of BPL-003 in combination with psychological support, a double-blinded randomized single ascending dose study was conducted on 44 psychedelic novices which were partitioned into six cohorts. Each cohort received either 1mg to 12mg of the drug or a placebo.
Initially, BPL-003 showed a dose that is proportionate to its pharmacokinetic profile and was well-tolerated with no serious side effects reported. Furthermore, it quickly began displaying its effects within minutes and had all of the alterations in consciousness worn off after 90 minutes.
It'll be interesting to see how this novel approach to tackling AUD pans out compared to existing treatments.
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.”
For more information please contact:
Beckley Psytech – www.beckleypsytech.com
Beckley Psytech Ltd is a private, clinical stage biotechnology company dedicated to improving the lives of people suffering from neuropsychiatric disorders by transforming psychedelics into effective and licensed medicines. The company’s most advanced programmes are focused on the development of psychedelic-based medicines to treat people with Treatment Resistant Depression (TRD), Alcohol Use Disorder (AUD) and Major Depressive Disorder (MDD). 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.
You may also like: Psilocybin Reduces Heavy Drinking in Patients With Alcohol Use Disorder