MindMed Publishes Phase 2b MM120 (LSD) Results In JAMA, Demonstrating Statistically Significant And Sustained Anxiety Reduction In GAD Patients; 100 µg Dose Achieved 65% Response, 48% Remission At Week 12, Supporting Ongoing Phase 3 Trials And FDA Breakthrough Therapy Designation

Author: Benzinga Newsdesk | September 04, 2025 11:15am

The Phase 2b study demonstrated a statistically significant dose-response relationship at the primary endpoint following a single administration of MM120 across four dose levels, with improvements sustained throughout the 12-week observation period

MM120 100 µg was determined to be the optimal dose, meeting its primary and key secondary endpoints, demonstrating a clinically and statistically significant improvement vs. placebo, and a 65% clinical response rate and 48% clinical remission rate at Week 12

MM120 was well-tolerated, with treatment-related adverse events occurring on dosing day and being consistent with the expected perceptual effects of LSD

Mind Medicine (MindMed) Inc. (NASDAQ:MNMD), (the "Company" or "MindMed"), a late-stage clinical biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced that JAMA has published full results from the Company's positive Phase 2b study of MM120 (lysergide D-tartrate, LSD) 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 (25, 50, 100, or 200 µg) 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 (HAM-A), a validated clinical tool used to assess the severity of anxiety.

The 100 µg 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 (-21.3 vs. -13.7; p<0.0004; Cohen's d=0.88) 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 (FDA) has provided Breakthrough Therapy Designation to MM120 for GAD.

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