Beckley Psytech will be presenting data from Part 1 of its Phase IIa study of BPL-003 (NCT05660642) for Treatment Resistant Depression (TRD) at the Society of Biological Psychiatry’s (SOBP) Annual Meeting.

The core, quadruple-masked, dose-finding study (NCT05870540) aims to evaluate the efficacy and safety of a single dose of BPL-003 (intranasal 5-MeO-DMT benzoate) in patients with Treatment Resistant Depression (TRD). An open-label extension of the study continues to enrol patients to evaluate the safety and efficacy of a second dose of BPL-003. Topline data from the core, randomised, 8-week study are expected in mid-2025.

A single dose of BPL-003 produced meaningful and sustained reductions in alcohol use, with 50% of patients maintaining complete abstinence over the 3-month observation period and the mean percentage of Heavy Drinking Days reducing from 56% in the pre-dose period to 13% 3-months post-dosing. These results come from Beckley Psytech’s Phase IIa open-label study (n=12) evaluating BPL-003 in combination with relapse prevention cognitive behavioural therapy for moderate-to-severe Alcohol Use Disorder (AUD). BPL-003 was also shown to be well-tolerated, with no serious or severe adverse events reported. Further results will be presented in 2025 and the team plan to use these findings to evaluate future development options for BPL-003 in substance use disorders.