atai Life Sciences Initiates Phase 2 Trial of EMP-01 for Social Anxiety Disorder

LOS ANGELES- atai Life Sciences has commenced a Phase 2 clinical trial evaluating EMP-01, an oral formulation of R-3,4-methylenedioxy-methamphetamine (R-MDMA), for the treatment of social anxiety disorder (SAD). The first patient has been dosed in this exploratory, randomized, double-blind, placebo-controlled study, which aims to assess the safety, tolerability, and efficacy of EMP-01 in approximately 60 adult participants diagnosed with SAD.

Participants in the trial will receive two administrations of either EMP-01 or a placebo, spaced four weeks apart. Symptoms will be monitored over a six-week period following the initial dose. The primary objective is to evaluate the safety and tolerability of EMP-01, with secondary objectives including the assessment of improvements in social anxiety symptoms compared to placebo.

In a prior Phase 1 study, EMP-01 demonstrated a unique, dose-dependent subjective effect profile that was generally found to be more similar to classical psychedelics than to racemic MDMA. This pharmacological profile suggests potential as a novel treatment option for SAD, a condition that affects approximately 18 million individuals in the United States and has seen limited advancements in approved therapies over the past two decades.