BPL-003 is Beckley Psytech’s patent-protected benzoate formulation of 5-MeO-DMT (also known as Mebufotenin) and is administered intranasally via an FDA-approved delivery device. The multi-centre, open-label Phase IIa study, currently recruiting at King’s College London and Hammersmith Medicines Research, will explore the effects of a single dose of BPL-003 in patients with Treatment Resistant Depression (TRD). Initial study results are expected in 2023.

Beckley Psytech Ltd, a private, clinical-stage biotechnology company dedicated to addressing neuropsychiatric disorders by transforming psychedelics into effective and licensed medicines, has announced that it will be presenting data from its Phase I study of BPL-003 at the Society of Biological Psychiatry’s Annual Meeting in San Diego, California, on the 27th - 29th April. Dr Frank Wiegand, Chief Medical Officer at Beckley Psytech, will deliver a poster presentation, titled 'Intranasal 5-MeO-DMT: Safety, PK and Effect on Altered States of Consciousness in Healthy Volunteers', on the 27th April from 5:30pm - 7:30pm PDT. 

The 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.

This is the first time the FDA has given IND approval for a Phase IIb study of a short-acting psychedelic like 5-MeO-DMT (Mebufotenin). Beckley Psytech plans to initiate the global multi-site Phase IIb study in H1 2023 to assess the efficacy, safety and tolerability of different doses of BPL-003 in patients with Treatment Resistant Depression (TRD). The study will take place across 40 investigator sites in 7 different countries, with study results expected in 2024.

Dosages for the Phase IIa programme were selected following the successful completion of the double-blind stage of Beckley Psytech’s Phase I study earlier this year, which showed that BPL-003 was well tolerated and had predictable pharmacokinetics and shortlasting pharmacodynamic effects. The multi-centre, open-label study will now investigate the safety, efficacy and pharmacokinetics of intranasal BPL-003 in patients with Treatment Resistant Depression (TRD), with a further Phase IIa study exploring the effects of BPL-003 in patients with Alcohol Use Disorder (AUD) planned for early 2023. The first participants in this TRD study are expected to be enrolled in January 2023.

Beckley Psytech Limited, a private, clinical stage biotechnology company dedicated to addressing neuropsychiatric conditions through the novel application of psychedelic medicines, announced today that Cosmo Feilding Mellen, Chief Executive Officer and Rob Conley, Chief Scientific Officer will be a panellist at Canaccord Genuity’s Symposium on New Paradigms and Treatment Approaches in Mental Health, taking place virtually on December 13th 2022. 

BPL-003 is Beckley Psytech’s patent-protected benzoate formulation of 5-MeO-DMT and is administered intranasally via an FDA-approved delivery device. In this study, BPL-003 was shown to be well-tolerated, with consistent dose delivery, highly reproducible pharmacokinetic profile and reliable induction of profound psychedelic experiences when dosed up to 12 mg in healthy participants. MHRA-approved Phase IIa studies of BPL-003 in Treatment Resistant Depression and Alcohol Use Disorder are expected to initiate in Q4 2022.

Beckley Psytech has dosed the first participant in their Phase I single-ascending dose (SAD) study of ELE-101, with top-line results expected in H1 2023. ELE-101 is a patent-protected, next-generation formulation of psilocin, the active metabolite of psilocybin, currently under clinical development for depression. ELE-101 is the second clinical-stage psychedelic compound in Beckley Psytech’s portfolio alongside BPL-003, the company’s lead candidate for upcoming MHRA-approved Phase IIa studies in depression and Alcohol Use Disorder (AUD).

Following on from last year, Beckley Psytech will again attend the Jefferies London Healthcare Conference and will hold a formal company presentation.

All equity acquisition adds short-acting psilocin candidate for broad range of indications to Beckley Psytech's portfolio of psychedelic assets. Expanded clinical pipeline will deliver multiple value inflection points over next 18 months. Phase 1 single ascending dose study of ELE-101 to initiate before the end of 2022. Lead 5-MeO-DMT formulation BPL-003 selected for upcoming Phase 2 studies in depression.