AtaiBeckley Inc. announced peer-reviewed publication of Phase 2a results for BPL-003 (mebufotenin benzoate nasal spray) in the Journal of Psychopharmacology, demonstrating rapid and durable antidepressant effects in treatment-resistant depression (TRD). Cohort 1, a 12-week open-label trial, enrolled 12 patients with moderate-to-severe TRD not taking concomitant antidepressants and received a single 10-milligram intranasal dose of BPL-003. The treatment produced a mean Montgomery–Åsberg Depression Rating Scale (MADRS) total score reduction of 12.6 points by Day 2, reducing from a baseline mean of 27.5 to 14.8, which was sustained over 12 weeks to a mean MADRS score of 14.5 at Day 85. A response rate of 54.5% was observed from the day after dosing through Day 85, and 63.6% of patients achieved remission with MADRS scores of 10 or below at one or more timepoints.
Safety and Efficacy Results
BPL-003 was well tolerated with no serious adverse events and no treatment withdrawals due to adverse events. Most adverse events were transient and mild-to-moderate in severity. Mean Snaith-Hamilton Pleasure Scale (SHAPS) scores improved from 8.4 at baseline to 1.5 at Day 85, indicating an absence of anhedonia. BPL-003 is a patent-protected intranasal formulation administered via nasal spray, designed to deliver rapid and durable effects from a single dose with a short psychedelic duration. The compound has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration and is covered by granted US, UK, and European composition-of-matter patents.
Clinical Development Timeline
Following a successful End-of-Phase 2 (EOP2) meeting with the FDA announced in March 2026, the Phase 3 program for BPL-003 in TRD remains on track for initiation in Q2 2026. The Phase 2a trial comprises four cohorts, with results from Parts 1, 2, and 3 previously announced. The first patient has been dosed in the Part 4 cohort, evaluating a two-dose induction regimen (8 milligrams plus 8 milligrams) of BPL-003 in TRD patients receiving defined antidepressants, with initial data expected in Q4 2026. AtaiBeckley’s broader pipeline includes VLS-01 (DMT buccal film) for TRD and EMP-01 ((R)-MDMA HCI) for social anxiety disorder, both in Phase 2 clinical development, and a drug discovery program to identify novel, non-hallucinogenic 5-HT2AR agonists for opioid use disorder and TRD.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.globenewswire.com/news-release/2026/03/17/3256934/0/en/BPL-003-Demonstrates-Rapid-and-Durable-Antidepressant-Effects-in-Treatment-Resistant-Depression-Phase-2a-Data-Published-in-Journal-of-Psychopharmacology-Phase-3-Program-on-Track-fo.html