atai Life Sciences announced positive topline data from Part 2 of Beckley Psytech's Phase 2a study (NCT05660642) of BPL-003 (mebufotenin benzoate), for treatment-resistant depression (TRD). The findings show that a single dose of BPL-003, when given to patients who were also taking defined selective serotonin reuptake inhibitors (SSRIs), was well-tolerated, with rapid and durable antidepressive effects of up to three months with an average in-clinic treatment time of less than two hours following dosing. These findings demonstrate the potential of BPL-003 to deliver a commercially scalable single dose treatment model, if approved, that fits within the current interventional psychiatric care model established by Spravato®?.
The results are also consistent with initial results from Part 1 of the study, which investigated BPL-003 as a monotherapy. Data from that study showed that a single dose of B PL-003 was well-tolerated and produced a rapid and lasting antidepressant effect for up to three months after dosing. Beckley Psytech is expecting results from the core, randomized, quadruple-masked stage of its Phase 2b study of BPL-003 for TRD in mid-2025.
In January 2024, atai made a strategic investment in Beckley Psytech, resulting in an approximate one third ownership stake and 1:1 warrant coverage at a 30% premium on the primary issuances. atai holds a time-limited right of first refusal on a future sale of the company and an indefinite right of first negotiation for BPL-003 and ELE-101. atai and Beckley Psytech also agreed to collaborate on digital therapeutics, commercial and market access activities in preparation for future potential commercialization.
