FDA grants approval to Beckley Psytech’s short-acting psychedelic trial

pharmafile | February 22, 2023 | News story | Research and Development  

Beckley Psytech, a private, clinical-stage biotech company, announced that the FDA has granted Investigational New Drug (IND) approval for their global multi-site phase 2b study into psychedelic drug BPL-003. BPL-003 is indicated for use in patients with Treatment Resistant Depression (TRD).


BPL-003 is a novel synthetic formulation of the psychedelic compound 5-MeO-DMT (Mebufotenin) and is administered intranasally via an FDA-approved delivery device.


This IND is the first that the FDA has given to a phase 2b study of a short-acting psychedelic or 5-MeO-DMT treatment. Phase 1 data has demonstrated that BPL-003 is well-tolerated with consistent dose delivery and a reproducible, dose-linear pharmacokinetic profile. The medium and high doses were found to reliably induce psychedelic effects, which correlated to positive clinical outcomes.


The 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. Participants will be patients with moderate to severe TRD who are not taking concomitant antidepressants. Efficacy will be assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) at several points throughout the trial.


CEO of Beckley Psytech Cosmo Feilding Mellen, said: “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 1 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.”


James Spargo

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