Positive Phase 1 EMP-01 (R-MDMA) Study Results

Clinical-stage biopharmaceutical company atai Life Sciences has reported positive outcomes from a Phase 1 study of EMP-01, an orally administered R-enantiomer of MDMA. The study's primary objectives were to assess the drug's safety, tolerability, pharmacokinetics, and pharmacodynamics. It involved 32 healthy individuals who were given varying doses of EMP-01 or a placebo in a randomized, double-blind setup.

The drug demonstrated a good safety profile with adverse events being expected and largely dose-dependent. No serious or severe adverse events were recorded, and there were no discontinuations due to these events. Minor increases in blood pressure and heart rate were noted, but they showed limited correlation with dosage. The study also observed that peak body temperatures remained within the normal range, and bruxism was only seen in one participant.

Pharmacokinetic results indicated that EMP-01's concentration in the body increased proportionally with the dose. The pharmacodynamic measures, which included subjective feedback and blood-based biomarkers, showed significant and consistent changes that were also dose-dependent. The subjective experience reported by participants differed from that of racemic MDMA, suggesting potential therapeutic benefits.

atai Life Sciences, founded to address the unmet needs in mental health treatment, is focused on developing innovative treatments for conditions such as depression, anxiety, and addiction. The company aims to expedite the development of new medicines to bring about significant and lasting behavioral changes in mental health patients.

The detailed data from the Phase 1 study is anticipated to be presented at an upcoming medical conference. Florian Brand, CEO and Co-Founder of atai, expressed gratitude for the successful completion of the study and highlighted the unique characteristics of EMP-01. Srinivas Rao, CSO of atai, noted the differences in the pharmacology of the two enantiomers of MDMA and suggested that R-MDMA could have broad applicability in mental health conditions.

atai's mission is to revolutionize mental health treatment to enable a more fulfilling life for all. The company is committed to responsible development and acceleration of new therapeutics for mental health disorders.