Atai Life Sciences (NASDAQ: ATAI), a leader in the biopharmaceutical sector, has successfully completed patient enrollment for the core stage of the global Phase 2b clinical trial for BPL-003 (mebufotenin benzoate). This trial, a critical step in addressing treatment-resistant depression (TRD), involves a detailed evaluation of a single dose of BPL-003 over an eight-week period. The study is conducted across 38 sites in six countries, with 196 patients participating.

The ongoing trial aims to confirm the efficacy and safety of BPL-003, following promising results from the Phase 2a study which demonstrated rapid and sustained antidepressant effects. The Phase 2b trial is noteworthy as it is the largest controlled study of its kind in the U.S. and pivotal for future regulatory discussions and Phase 3 planning slated for the second half of 2025.

BPL-003, developed by Beckley Psytech, is a proprietary intranasal formulation designed for rapid onset and durable effects. It is also being investigated for potential application in alcohol use disorder (AUD). Topline results from the trial are anticipated by mid-2025. Atai Life Sciences continues to invest in and support innovations aimed at transforming mental health treatment, with a strong focus on psychedelic medicines and digital therapeutics.

This trial underscores Atai’s commitment to pioneering new solutions for mental health disorders, reflecting their broader mission to enhance patient outcomes through novel therapeutic approaches. For more information, visit www.atai.life.

Read official post