atai Life Sciences (NASDAQ: ATAI), the tier-1 biopharmaceutical trialing psychedelic compounds for the treatment of mental health disorders, has unveiled positive findings from its Phase 1 investigation assessing the orally administered EMP-01—a R-enantiomer of MDMA (3,4-methylenedioxy-methamphetamine). An enantiomer is one of two stereoisomers that are mirror images of each other but cannot be superimposed onto one another.
The primary objectives of the Phase 1 study were to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of EMP-01. The study utilized a four-cohort, single-ascending dose, randomized, double-blind, placebo-controlled design, enrolling 32 healthy participants. These individuals were administered 75mg, 125mg, 175mg, or 225mg of EMP-01 or a placebo following a 6+2 design.
Phase I studies are range-finding trial, typically done to find the highest dose of the new treatment that can be given safely without causing severe side effects.
The results of the study ultimately met the primary objective. The administration of EMP-01 demonstrated excellent tolerability, with all treatment-related adverse events (AEs) being anticipated and generally exhibiting dose dependence. Notably, there were no study discontinuations, and the study did not observe any serious or severe AEs.
Although non-clinically significant increases in blood pressure and heart rate were recorded, these changes displayed limited dose dependency. Additionally, the peak body temperatures recorded fell within the normal range. Importantly, bruxism, a grinding of teeth, was observed in only 1 out of 24 subjects who received EMP-01.
The pharmacokinetic profile of atai Life Sciences’ EMP-01 displayed dose-proportional characteristics. Pharmacodynamic measures, encompassing both subjective reports and blood-based biomarkers, revealed significant, consistent, and dose-dependent alterations in several exploratory measures. The administration of EMP-01 led to a distinct subjective experience compared to racemic MDMA, as indicated by standard psychedelic experience questionnaires.
Furthermore, dose-dependent changes in measures of emotional breakthrough, a phenomenon believed to be a crucial mediator of the enduring psychological transformations associated with psychedelics, were observed in this healthy volunteer population.
A comprehensive presentation of detailed clinical data stemming from the Phase 1 study of EMP-01 is anticipated at an upcoming medical meeting.
TDR will have additional coverage on atai Life Sciences as the trial progresses.