MindMed Announces Promising Results from Phase 2b Trial of MM-120 for Generalized Anxiety Disorder

LOS ANGELES- Mind Medicine (MindMed) Inc, a biotech company focusing on psychedelic-inspired therapies, recently revealed encouraging topline results from its Phase 2b clinical trial of MM-120 (lysergide d-tartrate) in treating Generalized Anxiety Disorder (GAD). The trial’s success is significant, as it met its primary endpoint with MM-120 showing statistically significant improvements in anxiety symptoms compared to a placebo.

The study, involving 198 participants, was designed to test the efficacy of MM-120, administered as a single dose in a monitored clinical setting without any additional therapeutic intervention. Participants were randomized to receive varying doses of MM-120 (25, 50, 100, or 200 µg) or a placebo. The primary assessment tool was the Hamilton Anxiety rating scale (HAM-A), a widely recognized measure of anxiety severity. The results at Week 4 demonstrated dose-dependent improvements in HAM-A scores, indicating a robust response to MM-120, especially considering the severity of GAD symptoms in participants at baseline.

Robert Barrow, CEO and Director of MindMed, expressed enthusiasm over the trial’s positive outcomes. He highlighted the novelty of the study in assessing the standalone effects of MM-120 without psychotherapeutic interventions. Barrow emphasized the potential of MM-120 in revolutionizing treatment approaches for the millions affected by GAD, a condition that is often underdiagnosed and has significant impacts on work performance and labor force participation.

With an estimated 20 million people suffering from GAD in the United States, the successful progression of MM-120 through clinical trials holds promise for addressing a critical need in mental health care. The company anticipates sharing further study results, including 12-week data, in early 2024 and is preparing for a Phase 3 development program.

MindMed is poised to engage with the FDA in an End-of-Phase 2 meeting in the first half of 2024, a crucial step in advancing MM-120 into Phase 3 trials. The initiation of these trials is expected in the latter half of 2024. This advancement is a testament to MindMed’s commitment to developing innovative treatments for challenging mental health conditions and represents a hopeful future for those grappling with GAD.