Beckley Psytech said that the FDA has approved the company’s IND for a Phase 2b study comparing 2 doses of BPL–003 intranasal dry powder synthetic 5-MeO-DMT (mebufotenin) in patients with treatment-resistant depression. According to Beckley Psytech, the proposed Phase 2b study, which is expected to be initiated in the first half of this year, is the first ever approved by the FDA to evaluate any short-acting psychedelic therapy.
In November 2022, Beckley reported Phase 1 data for BPL-003 demonstrating that that the PK profile was dose proportional, with rapid onset, and consciousness-altering effects were short-lived. A Phase 2a study initiated in December 2022 is ongoing, and Beckley said that it expects to report data from that trial in 2024.
Beckley Psytech CEO 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 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.”
Chief Medical Officer Frank Wiegand added, “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.”
Read the Beckley Psytech press release.
