NEW YORK– Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), a late-stage clinical biopharmaceutical company, announced that the Journal of the American Medical Association (JAMA) has published results from its Phase 2b clinical trial of MM120 (lysergide D-tartrate, LSD) in adults with generalized anxiety disorder (GAD).
This was the first randomized, placebo-controlled study to test a single dose of MM120 across multiple dose levels without any study-related psychotherapy. Conducted in 198 patients with moderate-to-severe GAD, the trial showed a clear dose-response relationship and significant symptom reduction compared to placebo, as measured by the Hamilton Anxiety Rating Scale (HAM-A).
The 100 µg dose of MM120 achieved the strongest results. Patients treated at this level recorded a 7.6-point greater reduction in HAM-A scores than placebo at Week 4, with benefits lasting through Week 12. By the end of the study, 65 percent of patients responded to treatment and 48 percent achieved remission.
Adverse events were mostly mild to moderate, short-lived, and consistent with the expected perceptual effects of LSD. On the strength of these findings and the high unmet need in GAD treatment, the U.S. Food and Drug Administration (FDA) has granted MM120 Breakthrough Therapy Designation.
“This study is a true turning point in the field of psychiatry,” said Maurizio Fava, M.D., Chair of the Mass General Brigham Department of Psychiatry and member of the MindMed Scientific Advisory Board. “For the first time, LSD has been studied with modern scientific rigor, and the results are both clinically meaningful and potentially paradigm-shifting for the treatment of GAD.”
The trial also showed rapid improvements in clinical severity ratings and depressive symptoms, beginning as early as Day 2 and continuing through Week 12. Based on these results, MindMed has selected the 100 µg dose for its Phase 3 development program of MM120 Orally Disintegrating Tablet (ODT). The company is currently enrolling patients in its Voyage and Panorama trials for GAD and its Emerge trial for major depressive disorder. Topline data from Voyage are expected in the first half of 2026, with Panorama and Emerge results anticipated later that year.
“Our Phase 2b study demonstrates the meaningful impact of a single 100 µg dose of MM120 in significantly reducing anxiety symptoms,” said Daniel R. Karlin, M.D., M.A., Chief Medical Officer of MindMed. “These findings confirm that LSD can be studied rigorously and highlight its potential to transform psychiatric care.”
