ATAI Life Sciences(US:ATAI) Globenewswireยท2025-09-23 11:00Core Insights - atai Life Sciences and Beckley Psytech announced positive results from a proof-of-concept study of BPL-003 for treatment-resistant depression (TRD) [1][2] Study Overview - The Phase 2a open-label study enrolled 13 patients with TRD, with 12 completing the per-protocol analysis [2] - Patients received an 8 mg dose of BPL-003 followed by a 12 mg dose two weeks later, with assessments conducted over 12 weeks using validated depression rating scales [2][4] Key Findings - The two-dose regimen demonstrated rapid, clinically meaningful, and durable antidepressant effects, sustained for up to 3 months [4] - A second dose led to further reductions in MADRS scores, indicating enhanced clinical response beyond a single administration [4][5] - After the first dose, patients experienced a mean MADRS reduction of 13.3 points at Day 2 and 12.9 points at Day 8, with a total reduction of 19.0 points one week after the second dose [5] - Remission rates increased from 25% after the first dose to 50% at Week 8 and 42% at Week 12 [5] Safety and Tolerability - BPL-003 was well-tolerated, with all adverse events classified as mild to moderate, and no severe drug-related adverse events reported [5][10] - Patients met discharge readiness criteria within two hours after dosing, suggesting practical administration [5] Future Plans - The findings will inform the Phase 3 clinical program for BPL-003, with plans to engage with the FDA and other regulatory agencies [8][9] - The initiation of the Phase 3 clinical program is expected in the first half of 2026, pending FDA feedback [8] Company Background - atai Life Sciences focuses on developing effective mental health treatments, with a pipeline that includes psychedelic-based therapies for various mental health conditions [13] - Beckley Psytech is dedicated to developing rapid-acting psychedelic medicines for neuropsychiatric disorders, leveraging over two decades of scientific research [14]