AtaiBeckley (NASDAQ:ATAI) announced on Tuesday that results from a Phase 2a cohort evaluating BPL-003, its proprietary intranasal formulation of 5-MeO-DMT, have been published in the Journal of Psychopharmacology.
The data revealed that a single 10 mg dose led to a rapid 12.6-point mean reduction in the Montgomery–Åsberg Depression Rating Scale (MADRS) by the second day of treatment.
Notably, these gains were sustained through the 12-week follow-up period, with a mean MADRS score of 14.5 recorded at Day 85, compared to a baseline of 27.5.
The open-label study, which focused on patients with moderate-to-severe treatment-resistant depression (TRD) not taking concurrent antidepressants, reported a 54.5% response rate through three months.
Furthermore, approximately 63.6% of patients achieved clinical remission at one or more timepoints during the trial.
Beyond primary depression metrics, patients showed a significant reduction in anhedonia, with Snaith-Hamilton Pleasure Scale (SHAPS) scores improving from 8.4 at baseline to 1.5 by the end of the study.
From a safety perspective, BPL-003 was well-tolerated, with no serious adverse events or treatment withdrawals reported.
The treatment’s quick pharmacological profile allowed patients to be ready for clinic discharge within an average of two hours, a factor management believes will simplify integration into existing interventional psychiatry workflows.
The company recently completed a successful End-of-Phase 2 meeting with the U.S. Food and Drug Administration, confirming the design for two parallel Phase 3 studies, ReConnection-1 and ReConnection-2.
The move into pivotal trials, scheduled for the second quarter of 2026, comes at a critical time for AtaiBeckley.
The company recently redomiciled to the United States and reaffirmed a cash runway extending into early 2029, which is expected to fund the program through topline data readouts.