MindMed Collaborators Initiate Phase 1 Comparative PK/PD Trial of R-, S- and Racemic MDMA

- Study will compare the acute subjective, physiological, and endocrine effects of R-MDMA, S-MDMA, and racemic MDMA in 24 healthy subjects -

NEW YORK, Oct. 4, 2022 /PRNewswire/ -- Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (the "Company" or "MindMed"), a clinical stage biopharmaceutical company developing novel products to treat brain health disorders, today announced the initiation of a Phase 1 investigator-initiated trial led by MindMed collaborator Prof. Dr. Matthias Liechti at University Hospital Basel (UHB). The study aims to compare acute responses to R-MDMA, S-MDMA, and MDMA in healthy subjects.

"MDMA is a racemic substance containing equal amounts of the enantiomers S-MDMA and R-MDMA," said Prof. Dr. Liechti, principal investigator of the trial. "Preclinical research indicates that S-MDMA mainly releases dopamine, norepinephrine, serotonin, and oxytocin while R-MDMA may act more directly on 5-HT2A receptors and release prolactin. Animal studies indicate that R-MDMA may have fewer adverse effects and have greater prosocial effects. But the acute effects of S- and R-MDMA have never been validly examined in a human study. We are excited for the opportunity to potentially validate these findings in healthy human subjects."

Dr. Miri Halperin Wernli, Executive President of MindMed, added, "Although we know from animal studies that the two enantiomers act synergistically to produce the subjective effects of MDMA, this study represents an opportunity to validate the potential improved safety profile and prosocial effects of the R-enantiomer of MDMA. Preclinical studies of R-MDMA demonstrate its acute prosocial effects, while its diminished dopaminergic activity suggest that it will exhibit less stimulant activity, neurotoxicity, hyperthermia and abuse liability compared to racemic MDMA or the S-enantiomer. MindMed is developing MM-402 for the treatment of core symptoms of autism spectrum disorder (ASD), which is a developmental disorder characterized by atypical social communication and interactions, repetitive patterns of behavior and restricted interests. Despite its significant and growing prevalence, there are no therapies approved to treat the core symptoms of ASD. We look forward to exploring the exciting opportunities being unlocked by Dr. Liechti's research." 

The Phase 1 trial is a randomized, placebo-controlled, double-blind, 5-period crossover study. The trial plans to enroll 24 healthy subjects, who will receive R-MDMA (125 and 250mg), S-MDMA (125mg), MDMA (125mg), and a placebo. The primary outcome measures for this trial will assess acute subjective effects using the Visual Analog Scales (VAS) and the 5 Dimensions of Altered States of Consciousness (5D-ASC). Secondary endpoints will assess autonomic effects (blood pressure, heart rate, body temperature), mood on the days following the administration, endocrine effects, plasma concentration, and additional subjective effects (VAS, AMRS, SCQ, PIQ). More information about this trial is available at clinicaltrials.gov (identifier: NCT05277636) and at mindmed.co.

MindMed is a clinical stage biopharmaceutical company developing novel products to treat brain health disorders, with a particular focus on psychiatry, addiction, pain and neurology. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative drug candidates, with and without acute perceptual effects, targeting the serotonin, dopamine and acetylcholine systems.

MindMed trades on NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED.

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SOURCE Mind Medicine (MindMed) Inc.