Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) has recently announced the publication of results from their phase 2b study of MM120, also known as lysergide d-tartrate or LSD, in the Journal of the American Medical Association (JAMA). This groundbreaking study is the first-ever randomized, placebo-controlled clinical trial to assess the dose-dependent efficacy of MM120 in treating generalized anxiety disorder (GAD).
The study, which involved 198 adults with moderate-to-severe GAD, evaluated a single treatment across four dose levels (25, 50, 100, or 200 µg) as a monotherapy. The primary endpoint of the study was the Hamilton Anxiety Rating Scale (HAM-A), a validated clinical tool used to assess the severity of anxiety. The results demonstrated a statistically significant dose-response relationship at the primary endpoint, with MM120 100 µg being determined as the optimal dose. This dose met its primary and key secondary endpoints, showing a clinically and statistically significant improvement versus placebo, with a 65% clinical response rate and 48% clinical remission rate at week 12.
Notably, the 100 µg dose of MM120, which is now being evaluated in three pivotal phase 3 trials, achieved a 7.6-point greater reduction in HAM-A scores compared to placebo at week 4, with a 65% clinical response rate and 48% clinical remission rate sustained to week 12.
The study also assessed pre-specified secondary outcomes, including changes from baseline in depressive symptoms as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) and measures of functional disability and quality of life. The MM120 100 µg arm of the study showed clinically and statistically significant improvements compared to the placebo group, with a two-category shift in clinician-rated disease severity measured by the Clinical Global Impression-Severity (CGI-S) scale.
The study demonstrated that MM120 was generally well-tolerated, with most adverse events rated as mild-to-moderate, transient, occurring on the dosing day, and consistent with the expected acute effects of the trial drug.
Based on these phase 2b study results, the U.S. Food & Drug Administration (FDA) has provided breakthrough therapy designation to MM120 for GAD.
The company is currently enrolling participants in its phase 3 studies to further evaluate the efficacy, durability, and safety of MM120 orally disintegrating tablet (ODT) in the treatment of GAD. Topline data for these phase 3 trials is expected in the first and second half of 2026.
The MM120 study marks a significant milestone in the field of psychiatry, with the potential to offer a new treatment option for GAD, a condition that affects approximately 26 million adults in the U.S. and has seen little innovation in treatment in recent years.
MindMed's Chief Medical Officer, Daniel R. Karlin, M.D., M.A., stated that the phase 2b results "demonstrate the meaningful impact of a single 100 µg dose of MM120 in significantly reducing anxiety symptoms," and emphasized the potential for MM120 to transform the field of psychiatry.
Following these announcements, the company's shares moved -0.44%, and are now trading at a price of $9.02. Check out the company's full 8-K submission here.
