AtaiBeckley’s BPL-003 Cuts MADRS Score by 12.6 Points by Day 2
AtaiBeckley’s Phase 2a trial of its intranasal 10 mg BPL-003 in 12 treatment-resistant depression patients delivered a mean 12.6-point drop in MADRS score from 27.5 baseline to 14.8 at Day 2, sustained at 14.5 by Day 85. The 54.5% response rate and 63.6% remission rate showed durable effects.
1. Phase 2a Study Results
AtaiBeckley’s open-label Phase 2a cohort of 12 TRD patients received a single 10 mg intranasal dose of BPL-003, achieving a mean MADRS score reduction from 27.5 baseline to 14.8 at Day 2 (a 12.6-point drop), with scores maintained at 14.5 by Day 85. A 54.5% response rate and 63.6% remission rate were observed through the 12-week period.
2. Anhedonia and Safety Outcomes
Patients reported a decrease in Snaith–Hamilton Pleasure Scale scores from 8.4 at baseline to 1.5 by Day 85, indicating substantial anhedonia improvement. BPL-003 was generally well tolerated with no serious adverse events or discontinuations; most treatment-related events were mild to moderate and transient.
3. Trial Progression and Regulatory Pathway
The trial comprises four cohorts, with Cohort 4 evaluating a two-dose induction regimen in patients on defined antidepressants and initial data due in Q4 2026. Following an End-of-Phase 2 meeting with regulatory authorities, AtaiBeckley plans to initiate its Phase 3 program in Q2 2026.