MindMed Presents Phase 2b Study of MM120 for Generalized Anxiety Disorder (GAD) at American Psychiatric Association (APA) Annual Meeting in New York

Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today presented data from MMED008, its Phase 2b study of MM120 (lysergide d-tartrate) in the treatment of GAD in adults. MM120 demonstrated clinically and statistically significant efficacy compared to placebo at its primary week 4 and secondary week 12 timepoints. The study was presented at the APA Annual Meeting, the largest psychiatry-focused scientific meeting in the world, in New York City being held May 4 – 8, 2024.

MM120 demonstrated rapid, clinically meaningful, and statistically significant improvements on the Hamilton Anxiety rating scale (HAM-A) compared to placebo at Week 4, the study’s primary endpoint, and maintained durability of response to week 12. MM120 was administered as a single dose in a monitored clinical setting, with no additional therapeutic intervention, to demonstrate the medication’s effect.

“On behalf of the 20 million people in the US – and millions more worldwide – who are living with GAD, we are incredibly excited for the therapeutic potential that MM120 shows based on its rapid and robust efficacy, durably sustained for 12 weeks after a single dose in this study,” said Daniel R. Karlin, MD, MA, Chief Medical Officer of MindMed, who presented the Phase 2b MM120 study at APA. “Few new treatment options have shown robust activity in GAD, with the last new FDA approval occurring in 2007. We are committed to bringing MM120 to people living with GAD and are excited to move into the next phase of our development program.”

MM120 100µg – the dose with optimal clinical activity observed in the study – demonstrated a 7.7-point improvement over placebo at Week 12 (-21.9 MM120 vs. -14.2 placebo; p<0.003 Cohen’s d=0.81), with a 65% clinical response rate and a 48% clinical remission rate sustained to Week 12. Clinical Global Impressions - Severity (CGI-S) scores on average improved from 4.8 to 2.2 in the 100µg dose group, representing a two-category shift from ‘markedly ill’ to ‘borderline ill’ at Week 12 (p<0.004). This clinical activity was rapid, observed as early as study day 2, and durable with further improvements observed in mean HAM-A or CGI-S scores between Weeks 4 and 12.