ATAI Life Sciences NV, in collaboration with Beckley Psytech, has announced positive results from a Phase 2b study of BPL-003, a psychedelic therapy aimed at treating patients with treatment-resistant depression. The study achieved its primary and secondary endpoints, demonstrating rapid and durable antidepressive effects with a single 8 mg or 12 mg dose, and favorable tolerability with minimal in-clinic time. These results support the advancement of BPL-003 into Phase 3 clinical studies. ATAI and Beckley Psytech plan to engage with the U.S. Food and Drug Administration and other regulatory agencies to discuss the design of the Phase 3 trial. A conference call and live webcast to discuss the findings will be held on July 1, 2025, and an archived replay will be available on ATAI's corporate website.
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