BPL-003 shows rapid response in AtaiBeckley's Phase 2a trial

AtaiBeckley reported that 12 adults with treatment-resistant depression improved within two days after a single intranasal dose of BPL-003, with effects lasting up to 12 weeks and no serious adverse events reported.

AtaiBeckley announced mid-stage (Phase 2a) results for BPL-003, an experimental intranasal treatment for treatment-resistant depression. The study tested single 10 mg or 12 mg doses in adults who remained on stable SSRI therapy. Results were published in CNS Drugs and the company reported rapid symptom improvement and follow-up data through about 12 weeks. The article mentions that BPL-003 has Breakthrough Therapy Designation from the US Food and Drug Administration and that the company plans to begin Phase 3 in the second quarter of 2026. Key details: - The trial enrolled 12 adults with treatment-resistant depression who continued stable SSRI treatment. - 66.7% of participants showed a clinically significant symptom reduction by Day 2 after a single dose. - Responses at Day 85 were reported as 83% in the 10 mg group and 66.7% in the 12 mg group. - Symptom changes were measured with the Montgomery-Åsberg Depression Rating Scale (MADRS); average scores fell to remission-levels in the 10 mg group and near-remission in the 12 mg group. - No serious adverse events were reported; most side effects were transient and resolved the same day, and participants were discharged on average about 100 minutes after dosing. Summary: The reported Phase 2a data describe a rapid onset of symptom reduction after a single intranasal dose of BPL-003 and durability of response in many participants through roughly 12 weeks. Another cohort in the Phase 2a program remains ongoing with initial results expected in the fourth quarter of 2026, and the company plans to start Phase 3 in the second quarter of 2026.