AtaiBeckley Inc., a clinical-stage biotechnology company, announced its participation in the 64th Annual Meeting of the American College of Neuropsychopharmacology held January 12-15, 2026 in Nassau, The Bahamas, presenting new clinical and preclinical data on its mental health therapies. The company’s Phase 2b study results for BPL-003 (mebufotenin benzoate) nasal spray in patients with treatment-resistant depression (TRD) were selected for inclusion in the prestigious Hot Topics Session, a highly competitive forum reserved for the most compelling and impactful new findings.
Dr. David Feifel, Professor Emeritus of Psychiatry at the University of California, San Diego, presented efficacy and safety data showing that a single 8 mg or 12 mg dose of BPL-003 resulted in a significant, rapid, and sustained antidepressant effect compared with a 0.3 mg sub-perceptual dose control at all timepoints in the study, with both active dose levels being well-tolerated. The findings indicate the potential benefits of intranasal BPL-003 in treating TRD and highlight the need for further investigation in Phase 3 trials.
BPL-003 is a patent-protected, proprietary intranasal formulation of mebufotenin benzoate designed to deliver rapid and durable effects from a single dose, with a short psychedelic duration. It is being investigated as a potential therapy for treatment-resistant depression and alcohol use disorder. BPL-003 has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration and is covered by granted US, UK and European composition-of-matter patents, with multiple further claims pending in various jurisdictions.
Dr. Michelle Kokkinou, Senior Scientist, Non-Clinical Development at AtaiBeckley, presented preclinical findings on 5-MeO-DMT (mebufotenin), investigating in vitro binding, in vivo pharmacokinetics, efficacy and potential mechanism of action. The findings support effects of 5-MeO-DMT that are potentially relevant to its therapeutic use for treating mood disorders, highlighting therapeutic approaches for targeting neuroplasticity alterations thought to be implicated in individuals with mood disorders.
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