Beckley Psytech has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for a phase IIb study of its lead compound BPL–003 in patients with treatment-resistant depression (TRD), the company announced.
The seven-country, 40-site study will explore the safety, efficacy and tolerability of two distinct doses of BPL–003, Beckley Psytech’s novel synthetic formulation of the psychedelic compound 5-MeO-DMT (Mebufotenin).
This is the first time the FDA has ever granted IND approval for a phase IIb study of a short-acting psychedelic treatment, the company said.
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The study is expected to begin in the first half of 2023 and 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 antidepressants. Efficacy will be assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) at several time points during the trial.
Initial results are expected in 2024, the company 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,” CEO Cosmo Mellen said in a statement. “...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.”
Phase I data has shown BPL-003 to be well-tolerated with consistent dose delivery and a reproducible, dose-linear pharmacokinetic profile, the company said. 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.
“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,” chief medical officer Frank Wiegand said. “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”.
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