Atai Life Sciences (NASDAQ:ATAI) and Beckley Psytech Limited, a private clinical-stage biopharmaceutical company, released data from a proof-of-concept study investigating a two-dose induction regimen of BPL-003 (intranasal mebufotenin benzoate) in patients with treatment-resistant depression (TRD).
Patients were given an 8 mg dose of BPL-003 followed by a 12 mg dose two weeks later.
Key Findings
Following the first (8 mg) dose, patients experienced a mean MADRS (Montgomery-Asberg Depression Rating Scale) reduction of 13.3 points from baseline at Day 2 and a mean MADRS reduction of 12.9 at Day 8.
One week after the second dose (12 mg), the MADRS score further decreased to a total of 19.0-point reduction from baseline, with sustained antidepressant effects observed through Week 12 (13.7 points from baseline).
The findings suggest that a second dose of BPL-003 may further enhance the clinical response beyond what is achieved with a single administration.
The second dose of BPL-003 increased the proportion of patients meeting response and remission criteria for depression. Remitter rates one week after the initial 8mg dose were 25%, with rates doubling to 50% at Week 8 (6 weeks after the second dose administration) and 42% at Week 12.
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BPL-003 was shown to be generally well-tolerated, with all adverse events classified as mild to moderate, and there were no severe drug-related adverse events reported.
Patients met discharge readiness criteria within two hours after dosing for both doses, reinforcing the potential for BPL-003 to be integrated into the established interventional psychiatric treatment paradigm.
Dosing and follow-up in the open-label extension (OLE) stage of the Phase 2b study, which is evaluating the effects of a 12 mg dose of BPL-003 administered eight weeks after the initial dose in the core study, is complete, and data are expected in October.
Atai and Beckley Psytech are finalizing plans to engage with the U.S. Food and Drug Administration (FDA) and other regulatory agencies to discuss the design of the Phase 3 trials for BPL-003 in patients with TRD.
Pending FDA feedback, initiation of the Phase 3 program is expected in the first half of 2026.
HC Wainwright analyst Patrick Trucchio reiterates ATAI Life Sciences with a Buy and maintains a price forecast of $15.
Price Action: ATAI stock is up 16.80% at $5.70 at the last check on Tuesday.
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