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Tuesday, May 20, 2025

atai Positive Topline Data from Beckley Psytech’s Phase 2a in Treatment-Resistant Depression



atai Life Sciences (NASDAQ: ATAI) announced positive topline results from Part 2 of Beckley Psytech's Phase 2a study of BPL-003 for Treatment-Resistant Depression (TRD). The study evaluated a single dose of BPL-003 in combination with SSRIs in 12 patients with moderate-to-severe depression. Key findings include:

- Mean MADRS reduction of 18 points from baseline one day after dosing - Sustained efficacy with 19-point reduction at one month and 18-point reduction at three months - Average discharge time of less than two hours post-dosing - Well-tolerated with only mild to moderate adverse events

The company is currently conducting a larger Phase 2b study with 196 patients, the largest controlled clinical study of mebufotenin in the US, with results expected in mid-2025. These findings will support end-of-Phase 2 regulatory meetings and Phase 3 planning.

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