AtaiBeckley's BPL-003 Shows Rapid, Durable Antidepressant Response in Treatment-Resistant Depression Patients on SSRIs; Phase 2a Data Published in CNS Drugs

NEW YORK, April 08, 2026 (GLOBE NEWSWIRE) -- AtaiBeckley Inc. (NASDAQ: ATAI) (“AtaiBeckley” or “Company”), a clinical-stage biotechnology company on a mission to transform patient outcomes by developing rapid-acting, durable and convenient mental health treatments, today announced peer-reviewed Phase 2a results (NCT05660642) in CNS Drugs demonstrating that a single intranasal dose of BPL-003 (mebufotenin benzoate), which holds FDA Breakthrough Therapy Designation, achieved rapid and sustained reductions in MADRS scores from baseline in participants with treatment-resistant depression (TRD) who remained on stable SSRI therapy throughout the study (n=12). A 66.7% antidepressant response rate (≥50% reduction from baseline MADRS score) was observed at Day 2 in both the 10 mg (n=6) and 12 mg (n=6) cohorts, with 83% (5/6) of participants in the 10 mg cohort and 66.7% (4/6) of participants in the 12 mg cohort maintaining a response at Week 12. BPL-003 was generally well tolerated with no serious adverse events reported, and participants achieved a mean discharge approximately 100 minutes post-dose. Phase 3 studies are on track to initiate in Q2 2026 following recent FDA End-of-Phase 2 (EOP2) alignment.