atai Life Sciences Announces Positive Topline Data from Part 2 of Beckley Psytech's Phase 2a Study of BPL-003 in Combination with SSRIs for Treatment-Resistant Depression

Core Insights - Atai Life Sciences announced positive topline data from Beckley Psytech's Phase 2a study of BPL-003, indicating a rapid and durable antidepressant effect for treatment-resistant depression when administered with SSRIs [1][2][6] - BPL-003 was well-tolerated, with patients able to be discharged within an average of less than two hours after dosing [1][3] - The Phase 2b study results are expected in mid-2025, with 196 patients enrolled, marking it as the largest controlled clinical study for mebufotenin [7] Study Findings - A single dose of BPL-003 resulted in a mean MADRS reduction of 18 points from baseline the day after dosing, 19 points one month later, and 18 points three months post-dosing [4] - The open-label Phase 2a study involved 12 patients with moderate-to-severe depression who had not responded to at least two prior treatments [2][6] Treatment Context - BPL-003 is designed as a rapid and durable treatment for treatment-resistant depression and is administered via an intranasal spray [8] - The findings support the potential for BPL-003 to fit within the current interventional psychiatric care model, similar to Spravato® [5] Company Background - Atai Life Sciences is focused on developing effective mental health treatments, with a pipeline that includes other psychedelic-based therapies for various mental health conditions [12] - Beckley Psytech, in which Atai holds a significant stake, is dedicated to developing rapid-acting psychedelic medicines for neuropsychiatric disorders [11]