atai Life Sciences Announces Completion of Enrollment in Phase 2b Clinical Trial Evaluating BPL-003 for Treatment-Resistant Depression

Core Insights - The Phase 2b clinical trial of BPL-003 (mebufotenin benzoate) is evaluating its efficacy and safety in patients with treatment-resistant depression (TRD) [1][2] - The trial has completed patient enrollment, with 196 patients participating across 38 sites in six countries [2] - Topline results from the core stage of the Phase 2b clinical trial are expected in mid-2025 [1][4] Company Overview - atai Life Sciences is a clinical-stage biopharmaceutical company focused on transforming mental health treatment [7] - The company has a strategic investment in Beckley Psytech, holding approximately one-third ownership and collaborating on digital therapeutics and market access activities [6] Product Details - BPL-003 is a proprietary intranasal formulation designed for rapid and durable effects from a single dose, with a short time in clinic [5] - Initial Phase 2a data indicated that a single 10mg dose of BPL-003 produced rapid antidepressant responses, with 55% of patients in remission at Day 29 [4][5] Clinical Trial Design - The core stage of the Phase 2b trial is an eight-week, quadruple-masked, dose-finding study assessing medium (8mg) and high (12mg) doses against a sub-perceptual dose [2] - Efficacy is evaluated using the Montgomery-Asberg Depression Rating Scale (MADRS) at various time points [2]