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.

ELE-101 is Beckley Psytech's patent-protected synthetic intravenous (IV) formulation of psilocin benzoate designed to offer the therapeutic benefits of psilocybin in a more consistent, controllable, and shorter treatment paradigm of approximately two hours. In the small proof-of-concept study (n=6) in patients with Major Depressive Disorder (MDD), a single 10 minute infusion of ELE-101 was shown to induce rapid, robust and lasting antidepressant effects, with a mean >20 point reduction in MADRS scores observed at all time points through to 3 months after dosing. ELE-101 was also shown to be well-tolerated and patients were deemed ready to be discharged by Investigators within a mean time of approximately 2 hours. Study follow-up is complete and further data will be available in 2025 and will be used to inform the future clinical development of ELE-101.