Atai Life Sciences, Beckley Psytech Announce Positive Topline Results for BPL-003

Atai Life Sciences (NASDAQ:ATAI) is one of the best-performing NASDAQ stocks according to analysts. On July 1, Atai Life Sciences and Beckley Psytech Limited jointly announced positive topline results from the 8-week, quadruple-masked, dose-finding, core stage of their Phase 2b clinical trial evaluating the efficacy and safety of a single dose of BPL-003 in patients with treatment-resistant depression/TRD.

BPL-003 is Beckley Psytech’s patent-protected intranasal formulation of mebufotenin (5-MeO-DMT) benzoate, which is administered via a previously approved nasal spray device. The study enrolled 193 patients with moderate-to-severe TRD across 38 sites in 6 countries, including the US, and successfully met its primary and all key secondary endpoints.

Follow-up in the 8-week open-label extension/OLE stage of the study is ongoing, with 85% of eligible subjects from the core stage having enrolled. The OLE study is designed to evaluate the safety and efficacy of a second 12 mg dose of BPL-003 administered 8 weeks after the core study dosing. Data from the OLE study are expected in Q3 2025 and will provide further insights into the safety, tolerability, and durability of repeat dosing.

Atai Life Sciences (NASDAQ:ATAI) is a clinical-stage biopharmaceutical company that researches, develops, and commercializes mental health treatments in the US, Germany, and Canada. Beckley Psytech Ltd. is a private biopharmaceutical company.

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Disclosure: None. This article is originally published at Insider Monkey.