atai Life Sciences Reveals Promising Results from EMP-01 Phase 1 Study

NEW YORK- atai Life Sciences, a clinical-stage biopharmaceutical company, has announced encouraging results from its Phase 1 study of EMP-01, an orally administered R-enantiomer of MDMA. This study, a significant step in the company’s mission to revolutionize mental health treatment, was designed to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EMP-01.

The study enrolled 32 healthy participants in a four-cohort, single-ascending dose, randomized, double-blind, placebo-controlled format. Participants were administered doses ranging from 75mg to 225mg of EMP-01 or a placebo, following a 6+2 design. The results indicated that EMP-01 was generally well-tolerated, with treatment-related adverse events (AEs) being both expected and dose-dependent. Notably, there were no discontinuations due to adverse effects, and no serious or severe AEs were observed.

The study also revealed that the PK profile of EMP-01 was dose-proportional. Additionally, the PD measures, encompassing subjective reports and blood-based biomarkers, exhibited significant, consistent, and dose-dependent changes. One of the key findings was the differentiated subjective experience reported with EMP-01 administration compared to racemic MDMA, based on standard psychedelic experience questionnaires. This differentiation could have meaningful therapeutic implications, particularly in the context of emotional breakthrough, a phenomenon considered crucial in the long-term psychological changes associated with psychedelics.

These promising results pave the way for detailed clinical data, expected to be presented at a future medical meeting. Florian Brand, CEO and Co-Founder of atai Life Sciences, expressed gratitude to the participants, investigators, and the atai study team for the successful completion of this Phase 1 study. He emphasized the potential of EMP-01, building upon decades of research into MDMA as a treatment for mental health disorders.

Srinivas Rao, the CSO of atai, highlighted the unique pharmacology of the two enantiomers of MDMA. He noted the observed differences in subjective experience with R-MDMA compared to racemic MDMA, suggesting potential applicability in a broad array of mental conditions.

atai Life Sciences, founded in response to the significant unmet needs in mental health treatment, focuses on developing innovative therapeutics for depression, anxiety, addiction, and other mental health disorders. By pooling resources and best practices, atai aims to expedite the development of new medicines, aiming for clinically meaningful and sustained behavioral change in mental health patients.