Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), a clinical-stage biopharmaceutical company dedicated to pioneering innovative treatments for brain health disorders, has announced topline outcomes from its Phase 2b clinical trial of MM-120 (lysergide d-tartrate) targeting generalized anxiety disorder (GAD).
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TDR Key Points
- MindMed’s MM-120 met primary endpoint, showing statistically significant dose-dependent improvement in HAM-A scores four weeks post a single dose
- HAM-A reduction of 21.3 points, a 7.6-point improvement over placebo at Week 4
- Clinical response of 78% in 100 µg and 200 µg dose groups, with a 50% clinical remission rate observed in the 100 µg dose group at Week 4
- MM-120 generally well-tolerated, with predominantly mild-to-moderate adverse events occurring on dosing day
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According to MindMed, the trial successfully met its primary endpoint, revealing statistically significant and clinically significant dose-dependent enhancements in the Hamilton Anxiety Rating Scale (HAM-A) when compared to the placebo at Week 4. The administered single dose of MM-120 exhibited robust results with no additional therapeutic intervention.
HAM-A is a standardized and widely used clinical tool designed to assess the severity of anxiety symptoms in individuals. It consists of a series of questions and observations that evaluate both psychological and physical manifestations of anxiety. The scale covers various domains pertaining to anxiety such as mood, tension, and insomnia. Aggregate scores provide clinicians with a quantitative measure of the overall severity of anxiety, aiding in diagnosis and treatment planning for individuals experiencing anxiety disorders.
The 100 µg dose of MM-120, which demonstrated the highest clinical activity, showcased a significant 7.6-point reduction compared to the placebo at Week 4 (-21.3 MM-120 vs. -13.7 placebo; p<0.0004; Cohen’s d=0.88). In the 100 µg dose group. Clinical Global Impressions – Severity (CGI-S) scores exhibited a significant average improvement from 4.8 to 2.4 at Week 4, representing a two-category shift from ‘markedly ill’ to ‘borderline ill’ (p<0.001).
This clinical activity was observed to be both rapid and enduring, commencing on Day 2 and persisting through Week 4 with sustained effectiveness on both HAM-A and CGI-S.
Secondary and exploratory endpoints within the primary topline results included HAM-A response and remission rates and CGI-S scores. At Week 4, clinical response (50% or greater improvement in HAM-A) was achieved in 78% of MM-120-treated participants (100 µg or 200 µg) compared to 31% for the placebo. Clinical remission (HAM-A ≤ 7) at Week 4 was attained by 50% of participants treated with MM-120 100 µg. CGI-S scores showed a statistically significant and clinically meaningful improvement compared to the placebo in the 100 µg (p≤0.001) and 200 µg (p≤0.01) dose groups.
Participants receiving MM-120 (100 µg or 200 µg) experienced, on average, a 2-unit improvement in CGI-S scores at Week 4, with statistically significant enhancements observed as early as one day post-treatment and sustained across all evaluated time points through Week 4.
Overall MM-120 demonstrated good tolerability, with mainly transient mild-to-moderate adverse events (AEs) consistent with the pharmacodynamic effects of MM-120. The trial’s completion rate over four weeks was approximately 90%, reaching 97.5% in the high-dose groups, and none of the participants in the high-dose groups discontinued due to adverse events through Week 4.
MindMed anticipates that the study results will advance into Phase 3 clinical development for GAD. The company plans to convene an End-of-Phase 2 meeting with the FDA in the first half of 2024 and aims to commence Phase 3 clinical trials in the second half of 2024.
Further topline 12-week data from the study is expected to be presented in the first quarter of 2024, with full results to be shared at a scientific meeting later in the year.
TDR will have additional coverage as events warrant.