APA

APA 2024: Single dose of MM-120 (Lysergide) appears effective and safe for GAD

May 10, 2024

In this phase 2b randomized, placebo-controlled study of the efficacy of MM-120 (D-lysergic acid diethylamide D-tartrate) in patients with generalized anxiety disorder (GAD), researchers found that the 100µg dose achieved the highest level of clinical activity compared with placebo at week 4, and clinical activity was evident as early as day 2 after treatment. These findings, presented at the American Psychiatric Association Annual Meeting this week, suggest a rapid, robust, and durable clinical response to MM-120 in patients with GAD.

• A total of 198 adults 18-74 years old with GAD were randomized 1:1:1:1:1 to receive a single administration of MM-120 at a dose of 25µg (n=39), 50µg (n=40), 100µg (n=40), or 200µg (n=40) or placebo (n=39).
• Both 100µg and 200µg doses demonstrated clinically and statistically significant efficacy. The 100µg dose achieved the highest level of clinical activity with a statistically significant reduction of 7.6 points in HAM-A total score compared with placebo at week 4. Clinical activity was evident as early as day 2 after treatment as measured by the Clinical Global Impressions–Severity (CGI-S) scale.
• At week 4, 77.5% of subjects treated with MM-120 100µg showed a clinical response with ≥50% improvement in HAM-A vs. 30.77% with placebo. Further, 50% of participants treated with 100µg achieved remission (HAM-A ≤7) vs. 17.95% with placebo.
• Treatment-emergent adverse events occurred in 97.5% of participants in the MM-120 100µg group vs. 56.4% in the placebo group. Most events were mild to moderate, occurred on dosing day, and were consistent with the expected acute effects of MM-120.

Source:

Jacobsen P, et al. Rapid and Durable Response to a Single Dose of MM120 (Lysergide) in Generalized Anxiety Disorder: A Dose-Optimization Study. Poster P03-026. Presented at: American Psychiatric Association Annual Meeting; May 4-8, 2024; New York City, NY. 2024. https://s7.goeshow.com/apa/annual/2024/poster_search.cfm?session_key=00FF61DF-90B1-1C06-DFD2-922E6E4D0069&session_date=Saturday,%20May%2004,%202024