Atai Life Sciences announces topline results from phase 1 study of EMP-01

atai Life Sciences announced positive results from its Phase 1 study evaluating orally administered EMP-01, the R-enantiomer of MDMA. The goals of this Phase 1 study were to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics 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 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.