AtaiBeckley Inc. presented promising clinical data on BPL-003 for treatment-resistant depression at the American College of Neuropsychopharmacology annual meeting, with results recognized as a Hot Topic at the prestigious conference. The Phase 2b study findings showed that a single 8 mg or 12 mg dose resulted in significant, rapid and sustained antidepressant effects compared with a control group.
Study Findings
Dr. David Feifel presented efficacy and safety data from the Phase 2b study of BPL-003 nasal spray in patients with treatment-resistant depression. Results showed significant, rapid and sustained antidepressant effects at all timepoints in the study, with both active dose levels well-tolerated. The findings indicate potential benefits of intranasal BPL-003 and highlight the need for further investigation in Phase 3 trials.
About BPL-003
BPL-003 is a patent-protected intranasal formulation of mebufotenin benzoate being studied for treatment-resistant depression and alcohol use disorder. The drug has been granted Breakthrough Therapy designation by the FDA and is covered by granted US, UK and European composition-of-matter patents. AtaiBeckley also presented preclinical findings on 5-MeO-DMT, with Dr. Michelle Kokkinou sharing data suggesting its therapeutic potential for mood disorders.
Company Context
AtaiBeckley was formed through the strategic combination of atai Life Sciences and Beckley Psytech Limited in November 2025. The company’s pipeline includes VLS-01 (DMT buccal film) for treatment-resistant depression and EMP-01 (oral R-MDMA) for social anxiety disorder, both in Phase 2 clinical development. The company is also advancing a drug discovery program to identify novel, non-hallucinogenic 5-HT2AR agonists for opioid use disorder and treatment-resistant depression.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.quiverquant.com/news/AtaiBeckley+Inc.+Showcases+Breakthrough+Findings+on+BPL-003+for+Treatment-Resistant+Depression+at+ACNP+Annual+Meeting