Exploratory Safety and Efficacy of EMP-01 in Social Anxiety Disorder

This Phase IIa, multi-centre, double-blind, randomised, placebo-controlled trial (n=60) will investigate the safety, tolerability, and efficacy of EMP-01 in adults with social anxiety disorder (SAD). Participants will be randomised 1:1 to receive two administrations of either 225 mg EMP-01 or placebo on Day 1 and Day 29, with the primary endpoint assessed at Day 43.

The study, sponsored by Atai aims to explore the potential therapeutic effects of EMP-01, a novel R-enantiomer of MDMA, which has demonstrated enhanced serotonergic activity and fewer side effects compared to racemic MDMA. Previous research suggests that MDMA-like compounds can facilitate emotional processing, reduce social anxiety, and improve pro-social behaviours.

Participants will receive structured psychological support and be monitored for safety throughout the trial. The study is expected to begin in March 2025 and conclude in October 2025.

Trial Details

This Phase 2a, multi-center, double-blind, randomized, PBO-controlled trial will enroll approximately 60 participants (up to a maximum of 72) with SAD, randomized 1:1 to receive a total of 2 double-blind administrations of EMP-01 225 mg or PBO, on Day 1 and Day 29, during the blinded treatment period. The primary endpoint will be assessed 2 weeks after receiving the second blinded EMP-01 or PBO dose (EOS visit [Day 43]). Participants will be monitored for safety and to estimate the trajectory of their symptoms until the EOS Visit (Day 43). To maintain the double-blind, a central rater will be used for the secondary endpoint assessment of efficacy, which is the clinician-administered LSAS. A central rater will also be used to assess the Clinician Global Impressions-Improvement (CGI-I) scores (exploratory efficacy endpoint) and the Clinician Global Impressions-Severity (CGI-S) scores (eligibility to participate). This will be a trained rater, not belonging to the site, who will be remote and blinded to treatment group and visit number. All efforts should be made to ensure that, for each participant, each assessment is scored by the same rater. There is a risk that participants with SAD may experience acute distress during the study, including challenging experiences due to psychostimulant and psychedelic administration. In addition to receiving the investigational medicinal product (IMP), participants will receive standardized psychological support delivered by an appropriately credentialed and trained healthcare provider and will be monitored by a qualified mental health facilitator during IMP administration. Participants will complete validated clinician-administered and self-report measures of symptoms and related functioning throughout the study.

Trial Number NCT06693609

Data attribution

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