Atai Life Sciences And Merger Partner Set Up Psychedelic Depression Therapy With Encouraging Late-Stage Data
Atai Life Sciences (NASDAQ:ATAI) and Beckley Psytech Limited jointly announced topline results from the eight-week, quadruple-masked, dose-finding core stage of the Phase 2b trial of a single dose of BPL-003 (intranasal mebufotenin (5-MeO-DMT) benzoate) in patients with treatment-resistant depression (TRD).
The study achieved its primary endpoint as well as all key secondary endpoints.
In June, the companies announced their plan to combine in an all-share transaction, subject to the pre-agreed Phase 2b success criteria for BPL-003 (mebufotenin benzoate).
The transaction is expected to close in the second half of 2025.
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Key Efficacy Findings:
At Day 29, a single 12 mg dose of BPL-003 demonstrated a statistically significant reduction in depressive symptoms, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS), with a mean decrease of 11.1 points from baseline compared to a 5.8 point reduction in the 0.3 mg comparator group (p = 0.0038).
For the key secondary efficacy endpoints, a single 8 mg dose of BPL-003 also showed significant improvement at Day 29, with …