atai Life Sciences announced positive initial results from Beckley Psytech's Phase 2a open label study of BPL-003 in Treatment Resistant Depression (TRD), a condition that affects approximately 100 million people worldwide. BPL-003 is a novel, synthetic, patent-protected benzoate salt formulation of 5-MeO-DMT (mebufotenin) administered intranasally. Initial results demonstrated that a single 10mg dose of BPL-003 was well-tolerated and resulted in a rapid onset and durable antidepressant effect in patients living with TRD.

Acute effects resolved on average in less than two hours. These data suggest that BPL-003 could offer a shorter in-clinic treatment time when compared to other psychedelic treatments currently in development. A Part 2 extension of this Phase 2a open label study is now enrolling patients with TRD who are on stable doses of oral antidepressants to assess the safety and efficacy of BPL-003 co-administration (NCT05660642).

A randomized, quadruple-masked, controlled Phase 2b study of BPL-003 is currently underway (NCT05870540). The study is investigating the effects of a single 12mg or 8mg dose of BPL-003 against a sub-perceptual dose of 0.3mg in 225 patients with TRD. Efficacy will be assessed by masked raters using the MADRS scale at several time points with the primary endpoint at week 4 and final assessment at week 8. Top-line results are expected in H2 2024.