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Atai, Beckley Report Positive Phase 2a Results for Intranasal BPL-003 in Treatment-Resistant Depression
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Atai, Beckley Report Positive Phase 2a Results for Intranasal BPL-003 in Treatment-Resistant Depression
Sep 23, 2025 5:27 AM

08:02 AM EDT, 09/23/2025 (MT Newswires) -- atai Life Sciences ( ATAI ) said Tuesday that it and Beckley Psytech reported positive phase 2a open-label results for a two-dose induction of intranasal BPL-003 in treatment-resistant depression, with quick and sustained benefit lasting up to three months.

The regimen consisted 8 mg followed by 12 mg two weeks later, with the second dose resulting in additional reductions in the MADRS depression rating scale compared with a single administration, the company said.

Safety was generally favorable, with only mild to moderate adverse events and patients meeting discharge readiness within two hours after each dose, atai said.

These results will guide late-stage planning alongside data from Beckley's phase 2b study and its open-label extension expected in October, the company said.

atai also said the partners intend to discuss late-stage design with the US Food and Drug Administration and aim to start the program in H1 of next year.

Shares of the company were up by more than 2% in recent Tuesday premarket activity.

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