Mind Medicine Inc (NASDAQ: MNMD / NEO: MMED), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, announced today the upcoming presentation of preclinical data of MM-402, the Company’s proprietary form of the R-enantiomer of 3,4-Methylenedioxymethamphetamine (“MDMA”), in a model for autism spectrum disorder (“ASD”) at the ASCP 2023 Annual Meeting that is being held in Miami Beach, FL from May 30-June 2, 2023. The Company plans to initiate its first clinical trial of MM-402 in 2023.

he late-breaking poster entitled “MM-402, R(−)-3,4-Methylenedioxymethamphetamine, Demonstrates Prosocial and Therapeutic-Like Effects in Fmr1 Knockout Mice, a Preclinical Model of Autism Spectrum Disorder (due to Fragile X syndrome),” will be presented on Wednesday, May 31, 2023 at 11:15 am ET. This study demonstrated that administration of MM-402 increased social interaction in a characterized preclinical model of ASD. MM-402 exhibited a robust effect on social interaction and was more potent than racemic MDMA with reduced hyperactivity effects.

We are very pleased with these promising preclinical data, which provide the first evidence of prosocial activity of MM-402 in an ASD model and support the potential applications to enhancing social functioning in individuals with ASD. Importantly, MM-402 was able to achieve increased social interaction without the level of hyperactivity seen with racemic MDMA. With even further preclinical evidence to support our approach, we are extremely excited to initiate our Phase 1 clinical trial of MM-402 later this year.

Robert Barrow, Chief Executive Officer and Director of MindMed

In addition to MindMed’s preclinical research program for MM-402, MindMed’s collaborators at University Hospital Basel (“UHB”) in Switzerland are currently enrolling participants in a Phase 1 investigator-initiated trial of R-MDMA, S-MDMA and R/S-MDMA in healthy volunteers. 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 each receive doses of R-MDMA (125 and 250 mg), S-MDMA (125 mg), MDMA (125 mg), and placebo. Acute subjective effects in this study are being assessed using the Visual Analog Scales (“VAS”) and the 5 Dimensions of Altered States of Consciousness (“5D-ASC”) along with measurement of autonomic, endocrine and mood effects, among others. Additional information about this trial is available on our website (mindmed.co) and on clinicaltrials.gov (identifier: NCT05277636).

About MindMed

MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. 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 product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health disorders.