Atai Life Sciences announces FDA breakthrough designation for BPL-003

In a regulatory filing on Thursday, Atai Life Sciences (ATAI) said that it and Beckley Psytech announced that the U.S. Food and Drug Administration granted Breakthrough Therapy designation to BPL-003 for adult patients with treatment-resistant depression. BTD is granted to drugs targeting serious or life-threatening conditions where preliminary clinical evidence suggests that the drug may demonstrate substantial improvement on one or more clinically significant endpoints over existing therapies. BPL-003 is designed to deliver rapid and durable antidepressant effects from a single dose with a short therapeutic experience. The designation follows positive topline results from Beckley Psytech’s Phase 2b core, blinded study of BPL-003 in TRD which showed that a single administration of 8 mg or 12 mg of BPL-003 led to clinically meaningful and statistically significant reductions in depressive symptoms within 24 hours, with effects sustained through the eight-week trial period. Notably, most patients were deemed ready for discharge at the 90-minute post-dose assessment, underscoring the potential scalability of the BPL-003 treatment model and its potential to fit into the established two-hour, in-clinic interventional psychiatry treatment paradigm.