MM402 for Autism

Overseen By Mind Medicine, Inc. Clinical Trials Information Requests

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Definium Therapeutics

Disqualifiers: Psychotic disorder, Bipolar, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 day

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called MM402 for adults with Autism Spectrum Disorder (ASD). The goal is to determine if MM402 can improve social and communication skills in people with ASD. Participants may be suitable if they have an autism diagnosis and noticeable challenges in social interactions and communication. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Is there any evidence suggesting that MM402 is likely to be safe for humans?

Research has shown that MM402, also known as R-MDMA, is under study for its potential effects on autism. This treatment influences certain brain chemicals that affect mood and social behavior. In earlier studies, MM402 increased social interaction in animals, which is promising for people with autism.

However, specific safety information for humans is not yet available. As a Phase 2 study, MM402 has already passed initial safety tests in earlier phases, suggesting it might be well-tolerated. Researchers continue to monitor for any side effects to ensure participant safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for autism focus on behavioral therapies or medications that target symptoms like irritability but do not address the condition's underlying neurochemical factors. MM402 is unique because it uses R-MDMA, a psychoactive compound that primarily releases serotonin (5-HT) and also affects norepinephrine (NE) and dopamine (DA). This mechanism could modify some core symptoms of autism, potentially improving social interaction and communication in ways existing treatments do not. Researchers are excited because MM402 may offer a novel approach that directly influences brain chemistry, possibly leading to more comprehensive treatment outcomes for those with autism.

What evidence suggests that MM402 might be an effective treatment for autism?

Research has shown that MM402, also known as R-MDMA, might help treat autism. Studies have found that MM402 increases social interaction in animals with autism-like behaviors, suggesting it could also improve social behaviors in people with autism. In these studies, MM402 proved more effective than other similar treatments. Treatments like MM402, which resemble MDMA, are believed to help with social challenges related to autism by boosting certain brain chemicals that influence mood and social behavior. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

Adults aged 18 to 45 with Autism Spectrum Disorder (ASD) who show significant challenges in socialization and communication, as indicated by a score of ≥66 on the Social Responsiveness Scales (SRS-2). Participants must have a confirmed diagnosis of ASD. Those with eye movement issues, substance abuse disorders (except nicotine/caffeine), or personal/family history of psychotic/bipolar disorders are excluded.

Inclusion Criteria

Presents with clinically significant deficits in socialization and communication as determined by Social Responsiveness Scales (SRS-2) ≥66

Diagnosis of ASD per records as confirmed by standard semi-structured interview for Autism diagnosis (eg, Autism Diagnostic Observation Schedule-Second Edition)

I am between 18 and 45 years old.

Exclusion Criteria

Has uncorrected abnormalities in eye movement, alignment, or acuity or atypical eye features that could interfere with eye tracking

Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine)

A close family member has had psychosis or bipolar disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Single administration of 200 mg MM402 to evaluate effects in adults with ASD

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 days

Multiple assessments at 2, 4, 6, 8, and 24 hours post-dose and on day 15

What Are the Treatments Tested in This Trial?

Interventions

• MM402

Trial Overview

The trial is testing MM402, which is related to MDMA but designed for ASD. It's an open-label study where all participants know they're receiving the drug. The aim is to see if it helps improve social interaction and communication in adults with ASD.

How Is the Trial Designed?

Group I: 200 mg MM402 (R-MDMA) Experimental Treatment 1 Intervention

A psychoactive substance that mediates effects mainly through a release of the monoaminergic neurotransmitters, with the greatest effect on 5-HT, followed by NE and DA

Who Is Running the Clinical Trial?

Definium Therapeutics

Lead Sponsor

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07303907

A Phase 2A Trial of MM402 for Autism Spectrum Disorder

It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo ...

2.

mindmed.co

mindmed.co/news/press-release/mindmed-to-present-data-on-the-preclinical-activity-of-mm-402-at-the-36th-annual-european-college-of-neuropsychopharmacology-ecnp-congress/

MindMed to Present Data on the Preclinical Activity of MM-402 ...

This study demonstrated that administration of MM-402 increased social interaction in a characterized preclinical model of ASD.

3.

theglobeandmail.com

theglobeandmail.com/investing/markets/stocks/MNMD/pressreleases/36802068/mindmed-expands-into-autism-what-investors-should-know-about-the-new-mm402-trial/

MindMed Expands Into Autism: What Investors Should ...

Mind Medicine Inc. (MNMD) is running a Phase 2a clinical trial titled “An Open-label Study Evaluating MM402 in Adults With Autism Spectrum ...

4.

definiumtx.com

definiumtx.com/pipeline/dt402/

DT402 | MDMA Therapy for Autism Spectrum Disorder

“MM402 demonstrates better efficacy than S(+)-3,4-MDMA or (+)-3,4-MDMA in Fmr1 knockout mice, an animal model of autism spectrum disorder.” Presented at ECNP ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8686313/

A Systematic Review of the MDMA Model to Address Social ...

MDMA and/or MDMA-like molecules appear to be an effective pharmacological treatment for the social impairments of autism, at least in animal models.

6.

synapse.patsnap.com

synapse.patsnap.com/drug/0403fc76b1024469a8f89255b358a6d0

MM-402 - Drug Targets, Indications, Patents

We look forward to sharing 12-week safety, efficacy, and durability data and results from our Phase 1 pharmacokinetics bridging trial to support the ...