Atai Life Sciences' (NASDAQ:ATAI) wholly-owned subsidiary EmpathBio has received Medsafe central regulatory and the Health and Disability Ethics Committees (HDEC) approvals to begin participant enrollment in its Phase 1 trial of proprietary MDMA-based drug EMP-01, designed to treat PTSD and other mental health conditions.
The randomized, double-blind, placebo-controlled study intends to evaluate the safety and tolerability of single-ascending oral doses of EMP-01 in 32 healthy adult participants, as well as to assess the usability and acceptability of the IDEA-1 app in delivering “set and setting” content to participants in preparation for the drug administration.
The research, of which results are expected by the second half of 2023, will include a range of behavioral assessments that, together with the pharmacokinetics and safety results, would advise on the design of and doses tested in following Phase 2 trials of EMP-01.
EmpathBio develops MDMA derivatives with pharmacological profiles than differ from that of the first-generation psychedelic in the search of separating the drug’s entactogenic effects from its stimulant-associated effects.
The new compound may prove safer to use for the treatment of PTSD populations with comorbidities including hypertension, history of stroke and cardiovascular disease. If so, it could help minimize some of the physiological changes caused by MDMA while potentially expanding patient eligibility for this specific kind of therapy.
Glenn Short, senior VP, early development of atai, stated that although data on MDMA-assisted therapy strongly suggests its potential for PTSD treatment, the company is “focused on refining MDMA’s entactogenic pharmacology to provide a greater therapeutic index,” and eventually “ensuring that entactogen-assisted therapy is available to everyone who is struggling with PTSD.”
MDMA Therapy For PTSD
For the approximately 9.3 million people in the US who would fit the PTSD diagnosis, the FDA has only approved treatment via two selective serotonin reuptake inhibitors (SSRIs), paroxetine and sertraline, to which two-thirds of patients either do not respond or only partially respond.
MDMA is an amphetamine derivative believed to act by increasing the release of monoamines like serotonin, norepinephrine and dopamine in the brain, while also stimulating neurohormonal activity.
As advanced clinical research shows that brain and body activity induced by MDMA may result in the anxiolytic, prosocial and empathic responses commonly associated with its consumption is the reason why MDMA is often classified as an entactogen rather than just another psychedelic.
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