A growing number of companies have launched clinical trials for methylenedioxymethamphetamine (MDMA) and its derivatives.
The most recent is Atai Life Sciences, which saw its share price surge 7.71% in mid-day trading to $3.38 after announcing it had launched a Phase 1 study of an MDMA derivative, EMP-01. The study will focus on post-traumatic stress disorder (PTSD).
Last week, MindMed (Nasdaq: MNMD) announced that it had launched a Phase 1 study investigating MDMA-like substances in healthy volunteers.
Potential for PTSD and beyond
In 2020, Multidisciplinary Association for Psychedelic Studies (MAPS) completed a Phase 3 study of MDMA-assisted psychotherapy focused on PTSD. In addition, MAPS has Phase 2 studies underway for eating disorders, anxiety associated with a life-threatening illness and social anxiety in autism.
FDA has granted Breakthrough Therapy Designation to MAPS to test MDMA in PTSD.
Other companies investigating MDMA include Awakn Life Sciences Corp., which is testing its potential to treat addiction.
MDMA continues to be a Schedule I substance, which FDA classifies as having drugs “no currently accepted medical use” and “a high potential for abuse.” MAPS is advocating to have MDMA rescheduled as a Schedule III drug, which has “a moderate to low potential for physical and psychological dependence.”
The patent for MDMA, initially filed by Merck in 1912, expired nearly a century ago.
MDMA derivatives, however, can be patented.
Atai’s study of the EMP-01 MDMA derivative
The Atai subsidiary EmpathBio will test the safety and tolerability of oral EMP-01 in 32 healthy volunteers.
According to Glenn Short, senior vice president, the company believes its MDMA derivative could have “a greater therapeutic index” than traditional MDMA, early development of Atai Life Sciences. “However, we are focused on refining MDMA’s entactogenic pharmacology to provide a greater therapeutic index. This study is a critical step towards ensuring that entactogen-assisted therapy is available to everyone who is struggling with PTSD.”
The company plans to use behavioral assessments, pharmacokinetics data and safety readouts to inform the design of Phase 2 clinical studies of EMP-01.
Currently, the only FDA-approved drugs for PTSD are the SSRIs paroxetine and sertraline.
“The need for new interventions for PTSD is critical given the current lack of effective treatments for those suffering from this debilitating mental health disorder,” said Florian Brand, CEO of Atai Life Sciences, in a statement. “We are thrilled to have received the necessary approvals for the initiation of the Phase 1 trial for EMP-01 to further progress the potential development of this promising new therapy.”
Filed Under: Psychiatric/psychotropic drugs
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