Business
AtaiBeckley Announces Positive Topline Results from an Exploratory Phase 2a Trial of EMP-01 (oral R-MDMA) in Social Anxiety Disorder
EMP-01 met its primary objective on safety and tolerability, demonstrating a generally favorable and manageable safety and tolerability profileEMP-01
About this update from Ataibeckley Inc.
[{"type":"text","content":"EMP-01 met its primary objective on safety and tolerability, demonstrating a generally favorable and manageable safety and tolerability profileEMP-01 demonstrated a clinically meaningful placebo-adjusted least squares mean reduction of 11.85 points on the Liebowitz Social Anxiety Scale (LSAS) at Day 43 (Hedges’ g = 0.45; p-value = 0.036, one-tailed)EMP-01 demonstrated a robust separation from placebo on the Clinician Global Impression–Improvement (CGI-I) assessment: 49% responders vs. 15% for placebo, corresponding to a Number Needed to Treat (NNT) of 2.95EMP-01 demonstrated improvements across both Fear and Avoidance sub-domains of the LSAS, including improvement in social avoidance behaviors after two administrations over six weeks, and without adjunctive psychotherapyMore detailed analyses of the data will be described in upcoming scientific venues and will guide subsequent developmentConference call scheduled for 8:00 a.m. ET today, February 26, 2026 NEW YORK, Feb. 26, 2026 (GLOBE NEWSWIRE) -- AtaiBeckley Inc. (NASDAQ: ATAI) (“AtaiBeckley” or the “Company”), a clinical‑stage biotechnology company on a mission to transform patient outcomes by developing rapid‑acting, durable and convenient treatments for mental health conditions, today announced topline results from its exploratory, double‑blind, placebo‑controlled, first-in-patient Phase 2a study (NCT06693609) evaluating EMP‑01 (oral R‑MDMA) in adults with Social Anxiety Disorder (SAD). The study met its primary safety objective and generated encouraging secondary and exploratory efficacy signals in a highly severe, difficult‑to‑treat population. Commenting on the results, Professor Murray Stein, Distinguished Professor of Psychiatry and Public Health at the University of California San Diego (UCSD), and consultant to AtaiBeckley, said: “The initial findings from this trial of R-MDMA (EMP-01) are remarkable. Social Anxiety Disorder is a serious, often chronic and disabling condition affecting millions of Americans, and there have been no therapeutic advances in its pharmacological treatment in over 20 years. While preliminary, this study suggests that EMP-01 has the potential to make a tremendous impact on the lives of patients and their families. I hope future trials will be conducted to confirm these very exciting findings.” The multi-center study enrolled 71 adults with m...