MindMed’s (NASDAQ:MNMD) recurring collaborator, Prof. Dr. Matthias Liechti of the University Hospital Basel (UHB), will lead a novel Phase 1 clinical trial aiming to compare acute responses to R-MDMA, S-MDMA and MDMA in healthy subjects, which is set to begin on Tuesday.
The study will compare the acute subjective, physiological and endocrine effects of R-MDMA, S-MDMA and racemic -that is, a mixture with equal amounts of its component S and R enantiomers- MDMA in 24 unimpaired volunteers.
More specifically, in this Phase 1 randomized, placebo-controlled, double-blind, 5-period crossover trial, the patients will receive R-MDMA in doses of 125 and 250mg, S-MDMA in a 125mg dose, MDMA in a 125mg dose, and a placebo.
The focus is set on measuring acute subjective effects through the Visual Analog Scales (VAS) and the 5 Dimensions of Altered States of Consciousness (5D-ASC), while autonomic effects (blood pressure, heart rate, body temperature), post-administration general mood, endocrine effects, plasma concentration and any other subjective effects will also be assessed.
Dr. Liechti explained that existing preclinical research indicates S-MDMA mainly releases dopamine, norepinephrine, serotonin and oxytocin, while R-MDMA may act more directly on 5-HT2A receptors and release prolactin, therefore suggesting the latter enantiomer may have fewer adverse effects and greater prosocial effects than the former.
“But the acute effects of S- and R-MDMA have never been validly examined in a human study,” and that is what the current study aims to validate at a clinical stage.
MindMed’s executive president Dr. Miri Halperin Wernli added that although animal studies have shown 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.”
He further explained. “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.”
This is not the first time Dr. Liechti’s lab at the UHB and MindMed are working together, as shown by the recently announced Phase 1 trial comparing the effects of MDMA and other related substances.
MindMed’s goal is to develop a pipeline of innovative drugs with and without acute perceptual effects to target the serotonin, dopamine and acetylcholine systems for the treatment of various mental health disorders, including the undergoing development of MM-402 for the treatment of core symptoms of the autism spectrum disorder (ASD), a developmental condition “characterized by atypical social communication and interactions, repetitive patterns of behavior and restricted interests” for which there are no approved therapies yet.
“We look forward to exploring the exciting opportunities being unlocked by Dr. Liechti's research," stated Dr. Halperin Wernli.
Photo courtesy of Blue Planet Studio and Bacsica on Shutterstock.
