MindMed Announces Breakthrough in GAD Treatment with MM-120 in Clinical Trial

LOS ANGELES- Mind Medicine (MindMed) Inc., a clinical stage biopharmaceutical company, has reported promising results from its Phase 2b clinical trial of MM-120 (lysergide d-tartrate) in treating generalized anxiety disorder (GAD). The trial achieved its primary endpoint, with MM-120 showing significant improvements in the Hamilton Anxiety rating scale (HAM-A) compared to a placebo at Week 4.

The most effective dose of MM-120, 100 µg, demonstrated a notable 7.6-point reduction in HAM-A scores over placebo, marking a considerable improvement from ‘markedly ill’ to ‘borderline ill’. This result was both rapid and durable, with benefits observed from Day 2 through Week 4 without any loss of efficacy.

Robert Barrow, CEO and Director of MindMed, expressed optimism about the trial’s outcomes, emphasizing MM-120’s potential as a transformative treatment for GAD, a condition profoundly affecting millions worldwide. He acknowledged the trial participants, investigators, and the clinical development team for achieving this milestone.

Daniel Karlin, MD, MA, Chief Medical Officer of MindMed, highlighted the significant unmet need in GAD treatment. He pointed out the lack of new treatment options since 2004, underscoring the importance of MM-120’s robust and rapid clinical activity. This study’s unique approach—evaluating a drug candidate’s efficacy without concurrent therapeutic intervention—signals a potential revolution in treating brain health disorders.

The trial also included secondary and exploratory endpoints, such as HAM-A response and remission rates and Clinical Global Impressions – Severity (CGI-S) scores. A notable 78% of participants treated with MM-120 achieved a clinical response at Week 4, compared to 31% for placebo. Additionally, 50% of participants in the 100 µg group reached clinical remission. The CGI-S scores further confirmed MM-120’s significant and clinically meaningful improvement over placebo.

In terms of tolerability, MM-120 was generally well-received, with most adverse events being transient and mild-to-moderate, aligning with the pharmacodynamic effects of the drug. The four-week completion rate in the trial was approximately 90%, and notably, 97.5% in the high dose groups, with no discontinuations due to adverse events.

Looking ahead, MindMed anticipates that these results will pave the way for advancing MM-120 into Phase 3 clinical development for GAD. The company plans to meet with the FDA in the first half of 2024 and expects to initiate Phase 3 trials in the latter half of the year. Additional topline 12-week data from the study is expected in the first quarter of 2024, with full results to be presented at a scientific meeting later that year.