AtaiBeckley Inc. (NASDAQ:ATAI, XETRA:9VC) has announced the publication of results from its ongoing Phase 2a clinical study of its investigational treatment for treatment-resistant depression (TRD), BPL-003, reporting rapid and sustained antidepressant effects in a small patient cohort.
The data, published in the Journal of Psychopharmacology, comes from Cohort 1 of the four-part trial. This segment consisted of a 12-week, open-label study evaluating a single 10 mg intranasal dose of BPL-003 in 12 patients with moderate-to-severe TRD who were not taking concomitant antidepressants.
According to the company, patients experienced a mean reduction of 12.6 points on the Montgomery–Åsberg Depression Rating Scale (MADRS) by Day 2, with scores declining from a baseline average of 27.5 to 14.8. The effect was sustained over the 12-week study period, with a mean MADRS score of 14.5 recorded at Day 85.
A response rate of 54.5%, defined as at least a 50% reduction in MADRS score, was observed from the day after dosing through Day 85. In addition, 63.6% of patients achieved remission, defined as a MADRS score of 10 or below, at one or more timepoints during the study.
Measures of anhedonia also improved, with average scores on the Snaith-Hamilton Pleasure Scale decreasing from 8.4 at baseline to 1.5 at Day 85, indicating minimal symptoms by the end of the trial period.
BPL-003 was reported to be well tolerated, with no serious adverse events or treatment discontinuations linked to side effects. Most adverse events were described as transient and mild to moderate in severity.
The Phase 2a trial includes four cohorts. Results from the first three parts have previously been reported, and the fourth cohort is currently underway. This portion is evaluating a two-dose induction regimen in patients receiving defined antidepressants, with initial data expected in the fourth quarter of 2026.
Following a recent End-of-Phase 2 meeting with the US Food and Drug Administration, AtaiBeckley said it remains on track to initiate its Phase 3 program for BPL-003 in the second quarter of 2026.
“We are proud to be advancing a novel treatment designed to deliver rapid, durable results and integrate conveniently into clinical care,” AtaiBeckley CEO Srinivas Rao said in a statement.
“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.”