Atai Life Sciences subsidiary to begin trial of MDMA-based drug EMP-01

Atai Life Sciences' ATAI wholly-owned subsidiary EmpathBio has received the Health and Disability Ethics Committee's approval to begin participant enrollment in its Phase 1 trial of its 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 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 that differ from that of the first-generation psychedelic in the hope of separating the drug's entactogenic effects from its stimulant-associated effects.

The new compound could be safer for the treatment of PTSD populations with comorbidities, including hypertension, history of stroke and cardiovascular disease. If so, it could help minimize some physiological changes caused by MDMA while potentially expanding patient eligibility for this type of therapy.

Glenn Short, senior VP of 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. Two selective serotonin reuptake inhibitors SSRIs paroxetine and sertraline are two of the FDA's approved treatments for the approximately 9.3 million people in the US who would fit the PTSD diagnosis, and two-thirds of patients do not respond or only partially respond.

MDMA is an amphetamine derivative that is believed to act by increasing the release of monoamines like serotonin, norepinephrine and dopamine in the brain, while 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 associated with its consumption is the reason why MDMA is often classified as an entactogen rather than just another psychedelic.