- EMP-01 (R-MDMA) was generally well-tolerated and treatment-related adverse events (AEs) were as expected
- The PK profile of EMP-01 was dose-proportional, and a range of exploratory pharmacodynamic (PD) measures, including subjective reports and blood-based biomarkers, showed dose-dependent changes
- EMP-01 administration resulted in a differentiated subjective experience compared to racemic MDMA, a result that is likely to have therapeutic implications
atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, announced positive results from its Phase 1 study evaluating orally administered EMP-01, the R-enantiomer of MDMA (3,4-methylenedioxy-methamphetamine).
The goals of this Phase 1 study were to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EMP-01. The four-cohort, single-ascending dose, randomized, double-blind, placebo-controlled study enrolled 32 healthy participants who received 75mg, 125mg, 175mg or 225mg of EMP-01 or placebo in a 6+2 design.
EMP-01 was well-tolerated, and treatment-related adverse events (AEs) were all expected and generally dose dependent. There were no study discontinuations, and no serious or severe AEs were observed in the study. Non-clinically significant increases in blood pressure and heart rate were observed, though such changes showed limited dose dependency. Further, the peak body temperatures observed fell within the normal range. Finally, bruxism was observed in only 1 of 24 subjects that received EMP-01.
The PK profile of EMP-01 was dose-proportional. The PD measures included both subjective reports and blood-based biomarkers. Significant, consistent and dose-dependent changes were seen on several of these exploratory PD measures. EMP-01 administration resulted in a differentiated subjective experience compared to racemic MDMA on standard psychedelic experience questionnaires. Further, dose dependent changes on measures of emotional breakthrough, a phenomenon thought to be a key mediator of the long-term psychological changes associated with psychedelics, were noted in this healthy volunteer population.
Detailed clinical data from the Phase 1 study of EMP-01 are expected to be presented at a future medical meeting.
“I am grateful to the participants and investigators, as well as the members of the atai study team on the successful completion of this Phase 1 study. Building upon the decades of research into MDMA as a potential treatment for mental health disorders, including two positive Phase 3 studies in PTSD, we are encouraged by the unique characteristics of EMP-01 and exploring the implications for further clinical development.”
-Florian Brand, CEO and Co-Founder of atai
“The two enantiomers of MDMA show markedly different and rich pharmacology. The present study is one of the first specifically focused on assessing the PK and PD of R-MDMA. We found differences in the subjective experience R-MDMA in comparison to published reports involving racemic MDMA. If confirmed, these differences suggest that R-MDMA may have applicability in a broad array of mental conditions.”
-Srinivas Rao, CSO of atai
atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders and was founded as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders.
By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines to achieve clinically meaningful and sustained behavioral change in mental health patients.
atai’s vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life. For more information, please visit www.atai.life.