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Synthetic Psychedelic Compound Receives Investigational New Drug Approval
Beckley Psytech, a private, clinical-stage biotechnology firm, announced that it has received investigational new drug approval from the US Food and Drug Administration (FDA) for a global, multi-site Phase 2b study that will explore the safety, efficacy, and tolerability of 2 doses of BPL-003, a novel synthetic formulation of the psychedelic compound 5-MeO-DMT (mebufotenin), for patients diagnosed with treatment-resistant depression.
The approval is a first for a phase IIb study of a short-acting psychedelic treatment or a 5-MeO-DMT treatment. The study will be conducted across 40 sites in 7 countries, and is slated to begin in the first half of 2023. Initial results are expected in 2024.
“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,” Beckley Chief Medical Officer Frank Widgand, MD, PhD, said in a news release. “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.”
Data from a Phase I study showed BPL-003 to be well tolerated with consistent dose delivery and a reproducible, dose-linear pharmacokinetic profile. Medium and high dosages reliably produced psychedelic experiences that may be correlated with positive clinical outcomes. Psychedelic treatment effects were observed within minutes of administration, and all perceptual effects were resolved within a 60-to-90-minute period.
The Phase 2b randomized, dose-finding study will compare effects produced by a single medium or high dose of BPL-003 against a sub-perceptual dose in patients with moderate-to-severe treatment-resistant depression. Efficacy will be assessed by using the Montgomery-Asberg Depression Rating Scale at several points of the trial.
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