Beckley Psytech has announced the initiation of a Phase 2b trial of BPL-003 intranasal synthetic 5-MeO-DMT (mebufotenin) in people with moderate-to-severe treatment resistant depression. In February 2023, the company announced that the FDA approved an IND for the study. A Phase 2a trial of BPL-003 is still underway, Beckley said.
The Phase 2b study is expected to enroll 225 subjects who will receive a single dose of one of 3 dose levels of BPL-003 or intranasal placebo, with the primary endpoint as change from baseline on the Montgomery-Asberg Depression Rating Scale at 4 weeks post dose. Data from the trial are expected to be available in late 2024.
Beckley Psytech CEO Cosmo Feilding Mellen commented, “We’re proud to be leading the way in exploring how short-acting psychedelics like 5-MeO-DMT could help address the huge unmet need faced by millions of people living with treatment resistant depression around the world. BPL-003 has so far generated strong safety and pharmacokinetic data, and has been shown to reliably induce short-lasting and profound subjective effects, which correlate with positive therapeutic outcomes. We are optimistic about entering the next stage of clinical development of BPL-003 with this study and we are looking forward to sharing more in the coming months.”
Chief Scientific Officer Rob Conley said, “Getting to the first patient being dosed in this study has truly been a global collaboration. We’ve worked with international experts on the study design, trained around 170 therapists from around the world, and are collaborating with 40 highly qualified clinical trial sites in 6 different countries.”
Read the Beckley Psytech press release.
