The US Food and Drug Administration (FDA) has given IND approval for a Phase 2b study of a synthetic formulation of 5-MeO-DMT – BPL-003.
The development marks the first time the FDA has given IND approval for a Phase IIb study of a short-acting psychedelic.
Beckley Psytech has stated that it plans to initiate the global multi-site study in 2023 to assess the efficacy, safety and tolerability of different doses of BPL-003 – which is administered intranasally via an FDA-approved delivery device – in patients with Treatment Resistant Depression (TRD).
The study will take place across 40 investigator sites in seven different countries, with study results expected in 2024.
CEO of Beckley Psytech, Cosmo Feilding Mellen, commented: “This is a critical step towards our mission of delivering safe, effective and licensed psychedelic treatments to patients in need, and is also a significant milestone in the evolution of our clinical pipeline.
“It’s a privilege to be given the FDA’s first IND for a Phase 2b study of 5-MeO-DMT and it provides firm validation of the positive preclinical and Phase I data we have generated so far with BPL-003.
“This is an important step not only for Beckley Psytech, but also for the whole field of psychedelic drug development and, most importantly, for patients who are in urgent need of more effective treatments for mental health conditions such as depression.”
The company has said that Phase I data has so far shown BPL-003 to be well-tolerated with consistent dose delivery and a reproducible, dose-linear pharmacokinetic profile. Medium and high dosages were found to reliably induce profound psychedelic experiences, which might be correlated with positive clinical outcomes, with a rapid onset of psychedelic treatment effects within minutes.
Beckley Psytech’s Phase 2b randomised, dose-finding study will evaluate the effects of a single medium or high dose of BPL-003 against a sub-perceptual dose in patients with moderate to severe TRD who are not taking concomitant antidepressants.
The study will be quadruply masked, with the patient, investigator, attendant and outcomes assessor all blinded to the dose allocation of the subject to reduce expectancy bias. Efficacy will be assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) at several time points during the trial.
The study is fully funded from Beckley Psytech’s existing cash reserves and Beckley Psytech has stated that it will complement its ongoing Phase 2a study of BPL-003 for TRD.
Beckley Psytech’s Chief Medical Officer, Dr Frank Wiegand, also said: “The distinctive characteristics of BPL-003 make us optimistic about the compound’s potential to be a safe and effective alternative to currently available antidepressants.
“The rapid onset of effect, as well as the reliable induction and short duration of profound psychedelic experiences, are of great interest to us and we are excited to assess the therapeutic benefits of BPL-003 more deeply in this study.”
