AtaiBeckley announces positive topline results from an exploratory Phase 2a trial of oral R-MDMA EMP-01 in social anxiety disorder

oral R-MDMA (EMP-01) generated positive topline results in an exploratory Phase 2a trial for Social Anxiety Disorder. AtaiBeckley reports the study met its primary objective on safety and tolerability in adults with moderate-to-severe SAD, using two in-clinic administrations of 225 mg or placebo 28 days apart with no adjunctive psychotherapy. The company says no serious adverse events were observed and that most adverse events were mild or moderate. Efficacy signals were reported on the Liebowitz Social Anxiety Scale (LSAS), including a placebo-adjusted least squares mean reduction of 11.85 points at Day 43 (Hedges g = 0.45, p = 0.036, one-tailed) despite the trial not being powered for statistical significance. Clinician Global Impression-Improvement (CGI-I) results were also described as favorable, with 49% responders versus 15% on placebo (NNT = 2.95). AtaiBeckley states more detailed analyses will be presented at upcoming scientific venues and will guide later development.