Biopharma company Atai Life Sciences (NASDAQ: ATAI) shared positive results from a Phase 1 clinical study on MDMA R-enantiomer, EMP-01, under development for the potential treatment of PTSD.
Assessing EMP-01's safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD,) the study enrolled 32 healthy participants who, divided in four cohorts, received one dose of 75mg, 125mg, 175mg or 225mg of EMP-01 or placebo in a 6+2 design.
As reported by Atai:
The compound was well-tolerated and treatment-related adverse events were all expected, none severe and generally dose-dependent.
Non-clinically significant increases in blood pressure and heart rate were observed, yet changes showed limited dose dependency. Peak body temperatures observed were within the normal range, and bruxism was observed in 1 of 24 participants who received the ...