Beckley Psytech announced that a Phase 2a study of BPL-003 intranasal synthetic 5-MeO-DMT in people with alcohol use disorder demonstrated “meaningful and sustained reductions in alcohol use” for as long as 3 months post dose, with no serious or severe adverse events. The study, which was primarily designed to evaluate safety, enrolled 12 subjects with moderate-to-severe alcohol use disorder who received a single dose of BPL-003 along with cognitive behavioral therapy.
According to Beckley, at 12 weeks post dose, the mean number of alcohol units per day consumed by subject was reduced to 2.2 from 9.3 at the beginning of the trial. The mean percentage of days when subjects drank heavily was reduced from 56% pre-dosing to 13% and the mean percentage of days without any drinking rose from 33% to 81%, with 6 of the subjects not drinking at all for 12 weeks post dose.
The company is also developing BPL-003 for the treatment of treatment-resistant depression. In March 2024, Beckley announced that a Phase 2a trial of the intranasal psychedelic in patients with severe depression demonstrated a reduction in depressive symptoms. A Phase 2b trial of BPL-003 in treatment-resistant depression is underway, with results expected by mid-2025.
Beckley Psytech Chief Scientific and Medical Officer Rob Conley commented, “These findings contribute to a growing evidence base demonstrating the potential efficacy of psychedelic-based treatments to address the needs of those living with alcohol use disorder. We have shown that BPL-003 is safe and tolerable and that a single dose can deliver a rapid and durable effect within a short time in the clinic. We now plan to use this data to inform the development of further clinical studies that will investigate BPL-003 as an effective, rapid-acting, and accessible treatment option for substance use disorders. I would like to take this opportunity to thank the participants and research teams who have made this study possible.”
Read the Beckley Psytech press release
