The Phase IIa trial is a two-part, open-label study investigating the safety, tolerability and pharmacodynamics of BPL-003, Beckley Psytech’s novel, synthetic intranasal formulation of 5-MeO-DMT, in patients with Treatment Resistant Depression (TRD). Part 1 of the study was in patients who were not taking antidepressants. Initial results from that part, shared in March 2024, showed that a single dose of BPL-003 was safe and well-tolerated, with a rapid and durable antidepressant effect lasting up to 85 days post-dose. The first patient has now been dosed in Part 2 of the study, which will assess a single dose administration of BPL-003 in TRD patients who are also taking SSRI antidepressants in order to understand the effects of BPL-003 as an adjunctive therapy to SSRIs. Initial results from Part 2 of this study are expected in H1 2025.

BPL-003 is Beckley Psytech’s novel patent-protected benzoate salt formulation of 5-MeO-DMT that is administered intranasally. The Phase I, placebo-controlled, single ascending dose study was completed in November 2022 and explored the safety, tolerability, pharmacokinetics, and pharmacodynamics of BPL-003 alongside psychological support in healthy participants. BPL-003 was shown to be safe and well-tolerated in the study with a predictable pharmacokinetic profile and a reliable induction of psychedelic experiences with single doses of up to 12 mg in healthy participants. Psychedelic experiences correlated to 5-MeO-DMT exposure and had a rapid onset and short duration, with consciousness-altering effects resolving in less than 2 hours.

Initial results from Beckley Psytech's Phase IIa study of BPL-003 for Treatment Resistant Depression (TRD) show that a single 10mg dose of BPL-003 was well-tolerated with a short treatment duration and rapid, durable efficacy in patients with TRD. The initial findings increase confidence in Beckley Psytech's multi-centre Phase IIb study which seeks to further validate BPL-003’s safety and efficacy ahead of anticipated end-of-Phase II interactions with regulatory agencies.

Strategic investment in Beckley Psytech reinforces atai’s position as the biopharmaceutical company with the largest and most diverse portfolio of clinical-stage psychedelic candidates. Multiple clinical readouts are anticipated from this investment in Beckley Psytech within the next 12 months, including a Phase IIb readout of BPL-003 in Treatment Resistant Depression in 2H24. There are also multiple anticipated synergies expected through collaborating on digital therapeutics, commercial and market access activities in preparation for potential future commercialization.

BPL-003 is Beckley Psytech’s patent-protected benzoate formulation of 5-MeO-DMT and is administered intranasally via an FDA-approved delivery device. The multi-centre, quadruply-masked Phase IIb study aims to assess the efficacy and safety of different doses of BPL-003 in patients with Treatment Resistant Depression (TRD). The trial is thought to be the largest ever efficacy study of 5-MeO-DMT (also known as Mebufotenin) and is taking place at 40 sites across 6 countries, with initial study results expected in 2024.

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.