atai Life Sciences Announces First Patient Dosed in Phase 2 Study of EMP-01 for the Treatment of Social Anxiety Disorder

Core Insights - atai Life Sciences has initiated a Phase 2 study for EMP-01, an oral formulation of R-MDMA, targeting social anxiety disorder (SAD) [1][2][3] - The Phase 2 study aims to evaluate the safety, tolerability, and efficacy of EMP-01 in approximately 60 adults with SAD, with topline data expected in Q1 2026 [2][3] Company Overview - atai Life Sciences is a clinical-stage biopharmaceutical company focused on developing effective mental health treatments, including EMP-01 for SAD and VLS-01 for treatment-resistant depression [4] - The company is advancing a drug discovery program for novel, non-hallucinogenic 5-HT2AR agonists aimed at addressing complex mental health issues [4] Study Details - The Phase 2 study is randomized, double-blind, and placebo-controlled, with patients receiving either EMP-01 or placebo in a 1:1 ratio [2] - The primary objective is to assess safety and tolerability, while the secondary objective focuses on improvements in social anxiety symptoms compared to placebo [2][3]