LSD shows promise in treating generalized anxiety disorder, new study finds.

The Journal of the American Medical Association (JAMA) published a study on MM120 (Lysergide D-Tartrate, LSD) for Generalized Anxiety Disorder (GAD). The Phase 2b study showed a statistically significant dose-response relationship and improvements sustained throughout a 12-week observation period. The optimal dose of MM120 100 μg demonstrated a clinically and statistically significant improvement versus placebo, with a 65% clinical response rate and 48% clinical remission rate at Week 12. MM120 was well-tolerated, with treatment-related adverse events consistent with LSD's expected effects.

The Journal of the American Medical Association (JAMA) has published the full results of a Phase 2b study conducted by Mind Medicine Inc. (NASDAQ: MNMD) on MM120, a novel treatment candidate for Generalized Anxiety Disorder (GAD). The study, titled "MM120 (Lysergide D-Tartrate, LSD) in the Treatment of Generalized Anxiety Disorder: A Phase 2b, Randomized, Placebo-Controlled Trial," demonstrated statistically significant improvements in anxiety symptoms compared to placebo.

The study, which enrolled 198 adults with moderate-to-severe GAD, evaluated MM120 at four dose levels (25, 50, 100, or 200 µg) as a monotherapy. The primary endpoint was a dose-response relationship assessed by changes in the Hamilton Anxiety Rating Scale (HAM-A) from baseline to Weeks 4 and 8. The 100 µg dose of MM120 showed the optimal level of clinical activity, achieving a 7.6-point greater reduction in HAM-A scores compared to placebo at Week 4 (-21.3 vs. -13.7; p0.0004; 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, with treatment-related adverse events consistent with the expected acute effects of LSD. The most common adverse events included visual perceptual changes, nausea, and headache, all of which were mild to moderate and transient.

The study met its primary and key secondary endpoints, including improvements in anxiety symptoms, depression symptoms, and functional disability. The results highlight the potential of MM120 as a treatment option for GAD, which affects approximately 26 million U.S. adults and has a significant unmet medical need.

Based on these findings, the U.S. Food & Drug Administration (FDA) has granted MM120 Breakthrough Therapy Designation for GAD. MindMed is currently enrolling participants in three pivotal Phase 3 trials (Voyage, Panorama, and Emerge) to further evaluate the efficacy, durability, and safety of MM120 Orally Disintegrating Tablet (ODT) in the treatment of GAD and major depressive disorder (MDD).

The study findings represent a significant advancement in the field of psychiatry, as it is the first randomized, placebo-controlled trial to evaluate a single treatment with MM120 across multiple dose levels. The results suggest that MM120 could be a promising treatment option for GAD and other psychiatric disorders.

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[1] https://www.stocktitan.net/news/MNMD/journal-of-the-american-medical-association-jama-publishes-results-xtlj9ldik5ft.html