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MindMed announces Phase 1 study of MDMA-like substances

By Brian Buntz | September 21, 2022

MindMedOn 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.


Filed Under: clinical trials, Psychiatric/psychotropic drugs
Tagged With: MDA, MDMA, MindMed
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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