AtaiBeckley Reports Expanded Phase 2a Data for EMP-01 in Social Anxiety Disorder

NEW YORK – AtaiBeckley Inc., the clinical-stage biopharmaceutical firm born from the November merger of atai Life Sciences and Beckley Psytech, released additional results from its exploratory Phase 2a trial of EMP-01, an oral formulation of R-MDMA, in adults with moderate to severe social anxiety disorder (SAD).

The study, conducted at seven sites in the United Kingdom, enrolled 71 participants who received two 225-milligram doses of the drug or placebo, administered 28 days apart in a clinic setting without any accompanying psychotherapy. The trial met its primary goal of demonstrating safety and tolerability, with no serious adverse events reported and most side effects described as mild to moderate and self-resolving. Patient retention reached 97% through the Day 43 assessment.

On clinician-rated measures, 49% of those who received EMP-01 were judged “very much improved” or “much improved” on the Clinical Global Impression–Improvement scale, compared with 15% in the placebo group. That gap produced a number needed to treat of roughly 3. The company also reported a placebo-adjusted reduction of 11.85 points on the Liebowitz Social Anxiety Scale at Day 43, with a moderate effect size. Improvements appeared across both fear and avoidance subscales.

The newly detailed patient-reported outcomes showed still larger numerical differences. On the Social Phobia Inventory (SPIN), EMP-01 produced a 38% reduction from baseline versus 15% for placebo. Scores on the Subtle Avoidance Frequency Examination (SAFE) fell 32% in the treatment arm versus 14% with placebo. Both differences reached statistical significance in post-hoc analysis.

Social anxiety disorder affects an estimated 30 million adults in the United States alone and often proves difficult to treat with current options, which typically involve daily selective serotonin reuptake inhibitors or cognitive behavioral therapy over many weeks. EMP-01’s protocol of only two supervised doses stands in contrast to that approach.

AtaiBeckley has positioned EMP-01 as part of a broader pipeline that includes other short-acting compounds for mental health conditions. Company officials have said they plan to present full study details at upcoming scientific meetings and to discuss next steps with regulators.