Atai Beckley reported peer-reviewed Phase 2a Cohort 1 results for BPL-003 (mebufotenin benzoate nasal spray) in 12 patients with moderate-to-severe treatment-resistant depression who were not taking concomitant antidepressants. In this 12-week open-label trial, a single 10 mg intranasal dose reduced mean MADRS total score by 12.6 points by Day 2 and the mean score was 14.5 at Day 85. The response rate (≥50% MADRS reduction) was 54.5% from the day after dosing through Day 85, and 63.6% of patients achieved remission (MADRS ≤10) at one or more timepoints. The company said its Phase 3 program remains on track to initiate in Q2 2026, and initial data from a Part 4 cohort evaluating a two-dose induction regimen (8 mg + 8 mg) are expected in Q4 2026.

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