Mind Medicine announces publication of results from MM120 Phase 2b study

Mind Medicine (MNMD) announced that JAMA has published full results from the Company’s Phase 2b study of MM120 in 198 adults with moderate-to-severe GAD. This is the first randomized, placebo-controlled trial to evaluate a single treatment across four dose levels as a monotherapy and did not include any form of study-related psychotherapeutic intervention. The study met its primary and key secondary endpoints, with MM120 demonstrating a dose-response relationship and significant symptom improvement versus placebo on the Hamilton Anxiety Rating Scale, a validated clinical tool used to assess the severity of anxiety. The 100 microgram dose of MM120, now being evaluated in three pivotal Phase 3 trials, showed the optimal level of clinical activity in the study. At Week 4, it achieved a 7.6-point greater reduction in HAM-A scores compared to placebo with a 65% clinical response rate and 48% clinical remission rate sustained to Week 12. MM120 was generally well-tolerated in this study, with most adverse events rated as mild-to-moderate, transient, occurring on the dosing day, and being consistent with the expected acute effects of the trial drug. Based on these Phase 2b study results and the significant unmet medical need in the treatment of GAD, the U.S. Food & Drug Administration has provided Breakthrough Therapy Designation to MM120 for GAD. Pre-specified secondary outcomes in the study included changes from baseline in HAM-A; clinician-rated disease severity measured by Clinical Global Impression-Severity scale and changes from baseline in depressive symptoms as measured by Montgomery-Asberg Depression Rating Scale, in addition to measures of functional disability and quality of life. CGI-S scores on average improved from 4.8 to 2.2 in the 100 microgram dose group, representing a two-category shift from ‘markedly ill’ to ‘borderline ill’ at Week 12, compared with 4.9 to 3.5 in the placebo group. 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. MADRS score improvements in the 100 microgram arm of the study were clinically and statistically significant compared to the placebo group, with a difference of 5.7 points at Week 4 and a difference of 6.4 points at Week 12. The dose-response results support the selection of MM120 100 microgram for the Company’s ongoing Phase 3 development program for MM120 Orally Disintegrating Tablet. MindMed is currently enrolling participants in its Voyage and Panorama Phase 3 studies to assess the efficacy, durability, and safety of MM120 ODT in the treatment of GAD, and in its Emerge study to assess MM120 ODT for the treatment of major depressive disorder. Topline data for Voyage is expected in the first half of 2026 and for Panorama and Emerge in the second half of 2026.