AtaiBeckley’s BPL-003 Yields 66.7% Day-2 Response, Targets Phase 3 in Q2 2026
AtaiBeckley’s Phase 2a trial of intranasal BPL-003 in 12 treatment-resistant depression patients showed a 66.7% symptom reduction by Day 2, with responses maintained through Week 12 in 83% of the 10 mg cohort and 66.7% of the 12 mg cohort. No serious adverse events were reported and FDA granted Breakthrough Therapy status.
1. Phase 2a Trial Design and Efficacy
AtaiBeckley enrolled 12 adults with treatment-resistant depression on stable SSRI therapy, administering a single 10 mg or 12 mg intranasal dose of BPL-003 and assessing symptoms via the Montgomery-Åsberg Depression Rating Scale. By Day 2, 66.7% of participants achieved clinically significant symptom reduction, with sustained responses through Day 85 in 83% of the 10 mg cohort and 66.7% of the 12 mg cohort.
2. Safety and Tolerability
No serious adverse events were reported; most side effects were transient and resolved on the day of dosing. Participants were discharged on average 100 minutes after administration, highlighting the treatment’s rapid resolution of acute effects and feasibility in interventional settings.
3. Regulatory Status and Next Steps
BPL-003 has received Breakthrough Therapy designation, and AtaiBeckley plans to initiate Phase 3 trials in Q2 2026. An additional Phase 2a cohort remains underway, with initial results expected in Q4 2026, reinforcing the company’s development roadmap for its intranasal depression therapy.