Biopharma firm Atai Life Sciences ATAI has announced the positive outcomes of a Phase 1 clinical study on MDMA R-enantiomer, EMP-01, developed for the potential treatment of PTSD.

Assessing EMP-01’s safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD,) the study enrolled 32 healthy participants. They were divided into four cohorts that received one dose of 75mg, 125mg, 175mg, or 225mg of EMP-01 or placebo in a 6+2 design.

Atai  reported that:

• 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 psychedelic.

• EMP-01’s PK profile was dose-proportional. Exploratory PD measures included subjective reports and blood-based biomarkers, several of them showing “significant, consistent and dose-dependent” changes. 

• Administration showed a “differentiated” subjective experience compared to racemic MDMA on standard psychedelic experience questionnaires; and dose-dependent changes on measures of emotional breakthrough -one believed “key” mediator of the long-term psychological changes associated with psychedelics- were noted.

Atai CEO and co-founder Florian Brand highlighted EMP-01’s “unique characteristics” within the context of decades of research into MDMA as a potential treatment for mental health disorders, and said the team is set to explore the implications for further clinical development.

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Phase 1 studies are range-assessment trials, aiming to define the highest dose at which the new therapeutic can be provided safely, without causing serious side effects.

The study’s results ultimately met the primary objective, with EMP-01’s administration demonstrating great tolerability, and all treatment-related adverse events (none severe) being anticipated. Further, there were no trial discontinuations.

According to CSO Srinivas Rao, MDMA’s two enantiomers (S- and R-) show “markedly different and rich” pharmacology, and atai’s Phase 1 study -“one of the first specifically focused on assessing the PK and PD of R-MDMA-” showed differences in the subjective experience of R-MDMA as compared to published reports on racemic MDMA. 

If confirmed, Rao says these differences would suggest R-MDMA’s potential applicability “in a broad array of mental conditions.”

See Also: Breaking Down Molly: Swiss University Studies How MDMA’s Components Might Affect Humans

Atai will present further clinical data from the study at an upcoming medical meeting.

Photo: Benzinga edit with photo by Blue Planet Studio and ANDREI ASKIRKA on Shutterstock.