This is a paid press release. Contact the press release distributor directly with any inquiries.
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 for Q2 2026 Initiation
NEW YORK, March 17, 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 the peer-reviewed publication of results from its ongoing four-part Phase 2a study (NCT05660642) evaluating BPL-003 (mebufotenin benzoate nasal spray) in patients with treatment-resistant depression (TRD). Published in theJournal of Psychopharmacology, the newly reported data come from Cohort 1 – a 12 week, open-label trial of a single 10 mg intranasal dose of BPL-003 in 12 patients with moderate-to-severe TRD who were not taking concomitant antidepressants. BPL-003 produced a mean Montgomery–Åsberg Depression Rating Scale (MADRS) total score reduction of 12.6 points by Day 2 (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 (≥50% MADRS reduction) of 54.5% was observed from the day after dosing through Day 85, and 63.6% of patients achieved remission (MADRS ≤10) at one or more timepoints. Mean Snaith-Hamilton Pleasure Scale (SHAPS) scores also improved from 8.4 at baseline to 1.5 at Day 85, indicating an absence of anhedonia. 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.
Following a successful End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) announced in March 2026, the Phase 3 program for BPL-003 in TRD remains on track for initiation in Q2 2026.
“The publication of these findings in the Journal of Psychopharmacology is an important scientific milestone. In this first cohort, we saw a rapid 12.6-point mean reduction in MADRS scores by Day 2, which was sustained through 12 weeks on a single dose,” said Srinivas Rao, Co-Founder and Chief Executive Officer of AtaiBeckley. “We are proud to be advancing a novel treatment designed to deliver rapid, durable results and integrate conveniently into clinical care. With Phase 3 on track to initiate in Q2 2026, these peer-reviewed results reinforce our confidence in BPL-003’s potential to meaningfully address a critical unmet need for patients living with treatment-resistant depression.“
Clinical Development Update
The Phase 2a trial comprises four cohorts. Results from Parts 1, 2 and 3 have been previously announced. The first patient has been dosed in the Part 4 cohort, evaluating a two-dose induction regimen (8 mg + 8 mg) of BPL-003 in TRD patients receiving defined antidepressants, with initial data expected in Q4 2026.
Source: www.bing.com
