On the heels of launching a Phase 2b study of LSD in generalized anxiety disorder, MindMed (Nasdaq: MNMD) has dosed the first subject in a Phase 1 study evaluating MDMA-like substances in healthy volunteers.
MindMed is developing a synthetic enantiomer of MDMA as a potential treatment for core symptoms of autism spectrum disorder (ASD). Early evidence suggests that its MM-402 MDMA-based drug candidate can reduce social impairment.
Like LSD, MDMA (methylenedioxy-methamphetamine) is a Schedule I drug. While the U.S. government outlawed LSD in 1968, MDMA was banned in 1985.
The FDA, however, is purportedly considering approving MDMA as a treatment for post-traumatic stress disorder in the coming years.
Matthias Liechti, principal investigator of the Phase 1 study on MDMA-like substances on behalf of MindMed, noted that the amphetamines MDMA and methylenedioxyamphetamine (MDA) can have mixed subjective effects — especially at the onset of response.
Liechti is a professor of clinical pharmacology and internal medicine at the University of Basel.
The prodrugs Lys-MDMA and Lys-MDA are metabolized slowly to MDMA and MDA, respectively. They thus could offer “a novel and controlled delivery system of these active substances with potentially improved pharmacological properties,” Liechti said. “By using pharmacokinetics and modern psychological and psychometric tests, this study will investigate the potential to better control the bioavailability, slow the effect onset and reduce possible adverse effects of MDMA and MDA by using these prodrugs.”
Liechti also said that the study would be the first to test the effects of MDA in direct comparison with MDMA in humans.
The research will also investigate the tolerability, pharmacology and pharmacokinetics of novel MDMA-like compounds compared to a placebo.
Adverse effects of MDMA-like compounds can include blurred vision, temperature dysregulation, hypertension, tachycardia, sweating and dehydration.
MDMA, however, has shown dramatic promise in treating post-traumatic stress disorder. As a result, the FDA has designated MDMA-assisted therapy for PTSD a Breakthrough Therapy.
MindMed will retain exclusive rights to data from the study that could potentially inform its treatment model for its R(-)-MDMA drug candidate, MM-402.
Early clinical study results of MM-402 resulted in acute and durable improvements in social functioning in autism spectrum disorder.
The randomized, double-blinded Phase 1 clinical trial of MDMA-like substances aims to enroll 24 healthy subjects who will receive MDMA (100mg), MDA (93.9mg), Lys-MDMA (171.7 mg), Lys-MDA (165.6 mg) or placebo.