Pharma Focus Asia

Beckley Psytech Receives FDA Investigational New Drug (IND) Approval for Phase IIb study of BPL-003

Tuesday, February 21, 2023

Beckley Psytech announced that it had received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for a global multi-site Phase IIb study exploring the safety, efficacy and tolerability of two distinct doses of its lead compound, BPL–003, in patients with Treatment Resistant Depression (TRD).

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. This IND marks the first time the FDA has ever given IND approval for a Phase IIb study of a short-acting psychedelic treatment or a 5-MeO-DMT treatment. The study will be conducted with the help of 40 investigator sites in 7 different countries and is due to be initiated in H1 2023.

Beckley Psytech’s Phase IIb 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 not taking concomitant antidepressants.

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