Atai Life Sciences Experimental Depression Drug Shows Sustained Benefit In Treatment-Resistant Patients

Core Insights - Atai Life Sciences and Beckley Psytech Limited released positive data from a proof-of-concept study on BPL-003 for treatment-resistant depression (TRD) [1][2] Study Findings - Patients receiving the first 8 mg dose of BPL-003 showed a mean MADRS reduction of 13.3 points by Day 2 and 12.9 points by Day 8 [2] - After the second 12 mg dose, the total MADRS reduction reached 19.0 points from baseline, with sustained effects observed through Week 12, showing a 13.7-point reduction [2][3] - The second dose significantly increased the rates of patients meeting response and remission criteria, with remission rates rising from 25% after the first dose to 50% at Week 8 and 42% at Week 12 [3] Safety and Tolerability - BPL-003 was generally well-tolerated, with all adverse events classified as mild to moderate, and no severe drug-related adverse events reported [4] - Patients were ready for discharge within two hours post-dosing for both doses, indicating potential for integration into existing psychiatric treatment protocols [4] Future Developments - The open-label extension stage of the Phase 2b study is complete, with data expected in October [5] - Atai and Beckley Psytech are preparing to engage with the FDA regarding Phase 3 trial designs for BPL-003 in TRD patients, with initiation expected in the first half of 2026 pending FDA feedback [5][6] Market Reaction - Analyst Patrick Trucchio from HC Wainwright maintains a Buy rating on ATAI Life Sciences with a price forecast of $15, following a 16.80% increase in ATAI stock to $5.70 [6]