MindMed trial meets primary endpoint, FDA ‘End-of-Phase 2 meeting’ in 1H24

Mind Medicine or MindMed announced positive topline results from its Phase 2b clinical trial of MM-120, lysergide d-tartrate, in generalized anxiety disorder ,GAD,. The 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. MM-120 100 microgram – the dose achieving the highest level of clinical activity… “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. I would like to thank all of the participants in the study as well as the study investigators and our clinical development team, whose dedication made this important milestone possible.” Daniel Karlin, MD, MA, Chief Medical Officer of MindMed said, “Generalized anxiety disorder is a common condition associated with significant impairment that adversely affects millions of people and there remains a serious unmet need for this patient population. The pharmaceutical industry has largely ignored GAD over recent decades as it has proved extremely difficult to target. …”