Debra Borchardt
Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED) announced positive topline results from its Phase 2b clinical trial of MM-120 (lysergide d-tartrate) in generalized anxiety disorder (GAD). MindMed said that its trial met its primary endpoint, with MM-120 demonstrating statistically significant and clinically meaningful dose-dependent improvements on the Hamilton Anxiety rating scale (HAM-A) compared to placebo at Week 4.
MM-120 was administered as a single-dose in a monitored clinical setting with no additional therapeutic intervention. The trial enrolled 198 participants who were randomized to receive a single administration of MM-120 at a dose of 25, 50, 100 or 200 µg or placebo. The full analysis set (FAS) for the trial included 194 subjects, those that had at least one valid post-baseline Hamilton Anxiety rating scale (HAM-A) score. Subjects enrolled in the trial presented with severe GAD symptoms (average baseline HAM-A scores of approximately 30). While it is only four weeks of results, the response is seen as a very solid result.
“We are excited by the strong positive results for MM-120 in GAD, particularly given that this is the first study to assess the standalone drug effects of MM-120 in the absence of any psychotherapeutic intervention. These promising findings represent a major step forward in our goal to bring a paradigm-shifting treatment to the millions of patients who are profoundly impacted by GAD,” said Robert Barrow, Chief Executive Officer and Director of MindMed. “We look forward to sharing additional study results in the coming months – including topline 12-week results in the first quarter of 2024 – and working closely with FDA as we finalize the Phase 3 development program for MM-120 in GAD.”
Around 20 million people, currently suffer from GAD, an underdiagnosed and underserved indication that is associated with significant impairment, less accomplishment at work and reduced labor force participation.
Looking ahead, MindMed said it expects that the results of this study will support the advancement of MM-120 into Phase 3 clinical development for GAD. The company also said it plans to hold an End-of-Phase 2 meeting with the FDA in the first half of 2024 and expects to initiate Phase 3 clinical trials in the second half of 2024.
