MindMed's 2024 Plans: Anxiety Treatment Stands, LSD Microdosing For ADHD Will Be Discontinued

Earlier this week, biopharma company Mind Medicine (MindMed) MNMD released latest clinical trial results on repeated sub-perceptual doses of its LSD compound, MM-120, in adults with ADHD. The company also provided a corporate update and outlook for 2024.

Clinical Development: Present & Future

MM-120 is Mind Medicine’s lead drug candidate. It’s a tartrate salt form of lysergide (aka LSD) a synthetic tryptamine within the “classic” group of psychedelics that acts as a partial agonist at human serotonin-2A (5-hydroxytryptamine-2A [5-HT2A]) receptors.

MindMed is assessing MM-120 as a potential treatment for Generalized Anxiety Disorder (GAD.) At the advanced clinical stage and having recently provided both statistically significant and clinical topline results (4-week follow-up) in a nearly 200-patient cohort, some of the top features of the results include: 

• 100 micrograms achieved the highest level of clinical activity, greatly reducing anxiety in patients by week 4 and eliciting clinical remission in 50% of them.

• Along with the 200 microgram dose, they elicited a 50%+ improvement in 78% of participants four weeks post-administration.

More study details here.

MindMed also tried MM-120, in repeated sub-perceptual doses of 20 micrograms, as Attention-Deficit/Hyperactivity Disorder (ADHD) therapy. This 53-patient Phase 2a trial on the treatment’s safety and efficacy did not meet its primary endpoint.

The company announced that, in conjunction with the findings from the GAD study, they believe results “support the critical role of perceptual effects of MM-120 in mediating a clinical response.” 

Future activities will prioritize the development of MM-120 for GAD and “other psychiatric indications,” using the single perceptual dose (100 micrograms or greater) regimen “that has shown strong positive results in numerous studies,” the team said.

MindMed’s second psychedelic compound in development is MM-402, a novel form of MDMA's R enantiomer. Preclinical studies of R(-)-MDMA show its acute pro-social and empathogenic effects. At the same time, its lessened dopaminergic activity suggests a potential for promoting less stimulant activity, neurotoxicity, hyperthermia and abuse liability compared to MDMA or its S enantiomer.

MindMed is targeting MM-402 as a potential treatment of core symptoms of autism spectrum disorder (ASD) for which it has commenced its first clinical trial in Q4 2023. 

The Phase 1 study assesses MM-402 at a single-ascending dose in adult healthy volunteers. It’s expected to provide details on the psychedelic's safety and efficacy and eventually enable more clinical studies on repeated daily doses, nearing efficacy assessment in the ASD population.

MindMed’s research collaborator, Swiss UHB, is now conducting a Phase 1 study comparing the safety and efficacy of R(-)-MDMA, S(+)-MDMA and R/S-MDMA in healthy adult volunteers. Topline results would come in by H1 2024.

Management Comments

CEO Robert Barrow said the company’s strong progress in 2023 was reflected in the Phase 2b study on GAD's topline results.

The results, he added, reinforce MindMed's scientific understanding of the psychedelic’s mechanism of action and “emphasize the critical role we believe the perceptual effects of MM-120 play in driving clinical outcomes” (again, vs. sub-perceptual or microdoses.)

The company will enter 2024 with an “enhanced” focus on MM-120’s clinical program. 

MindMed plans to hold an end-of-Phase 2 meeting with the FDA in H1 2024 and expects to initiate its Phase 3 clinical program in H2 2024.

Photo: Benzinga edit with photo by Romolo Tavani and Sendo Serra on Shutterstock.