Poster
5
(#5) Rapid Extended Relief in a Dose-Optimization Study of Single Dose MM120 (Lysergide) in Generalized Anxiety Disorder
Psych Congress 2025
Abstract: Background: Generalized Anxiety Disorder (GAD) is among the most common psychiatric disorders; however effective and well-tolerated pharmacotherapies remain an unmet need. This study evaluated 4 doses of MM120 (lysergide D-tartrate; LSD) versus placebo in participants diagnosed with GAD.
Methods: This phase 2b double-blind, placebo-controlled study enrolled adults 18 to 74 with moderate-to-severe anxiety (Hamilton Anxiety Scale (HAM-A) ≥20). Participants received a single administration of MM120 of 25µg, 50µg, 100µg, 200µg, or placebo. Primary and key secondary objectives assessed the dose-response relationship of MM120, evaluating change in HAM-A from baseline to weeks 4 and 8. Safety assessments were performed at all timepoints.
Results: Statistically significant dose-response relationship was found at week 4 and week 8 (n=198). At week 4, the MM120 100µg dose showed a 7.6-point reduction in HAM-A compared to placebo and 77.5% of subjects treated with 100µg showed clinical response (≥50% improvement in HAM-A) versus 30.8% with placebo. Further, 50% of participants treated with 100µg achieved remission (HAM-A ≤7) versus 17.95% with placebo. Treatment-emergent adverse events (TEAEs) occurred in 97.5% in the 100µg group versus 56.4% in the placebo group. Most events were mild-to-moderate and consistent with expected acute effects of MM120.
Conclusion: Findings suggest rapid and durable dose-dependent clinical response to MM120 in participants with moderate-to-severe GAD with no identified safety concerns. Results demonstrate that 100 µg is an optimal dose for further development.
Funding: Mind Medicine (MindMed), Inc. supported this study.
Trial registration: NCT05407064, A Dose-Finding Study of MM120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms
Short Description: This Phase 2b study assessed the dose-response relationship of MM120 by evaluating the change in HAM-A from baseline to weeks 4 and 8 in patients with moderate-to-severe GAD. A statistically significant dose-response relationship was observed at weeks 4 and 8. The 100µg dose at week 4 showed a ≥50% improvement in HAM-A, versus 30.8% with placebo. Most side effects were mild-to-moderate occurring on dosing day. Results demonstrated that 100µg dose is optimal for further development.
Name of Sponsoring Organization(s):
Methods: This phase 2b double-blind, placebo-controlled study enrolled adults 18 to 74 with moderate-to-severe anxiety (Hamilton Anxiety Scale (HAM-A) ≥20). Participants received a single administration of MM120 of 25µg, 50µg, 100µg, 200µg, or placebo. Primary and key secondary objectives assessed the dose-response relationship of MM120, evaluating change in HAM-A from baseline to weeks 4 and 8. Safety assessments were performed at all timepoints.
Results: Statistically significant dose-response relationship was found at week 4 and week 8 (n=198). At week 4, the MM120 100µg dose showed a 7.6-point reduction in HAM-A compared to placebo and 77.5% of subjects treated with 100µg showed clinical response (≥50% improvement in HAM-A) versus 30.8% with placebo. Further, 50% of participants treated with 100µg achieved remission (HAM-A ≤7) versus 17.95% with placebo. Treatment-emergent adverse events (TEAEs) occurred in 97.5% in the 100µg group versus 56.4% in the placebo group. Most events were mild-to-moderate and consistent with expected acute effects of MM120.
Conclusion: Findings suggest rapid and durable dose-dependent clinical response to MM120 in participants with moderate-to-severe GAD with no identified safety concerns. Results demonstrate that 100 µg is an optimal dose for further development.
Funding: Mind Medicine (MindMed), Inc. supported this study.
Trial registration: NCT05407064, A Dose-Finding Study of MM120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms
Short Description: This Phase 2b study assessed the dose-response relationship of MM120 by evaluating the change in HAM-A from baseline to weeks 4 and 8 in patients with moderate-to-severe GAD. A statistically significant dose-response relationship was observed at weeks 4 and 8. The 100µg dose at week 4 showed a ≥50% improvement in HAM-A, versus 30.8% with placebo. Most side effects were mild-to-moderate occurring on dosing day. Results demonstrated that 100µg dose is optimal for further development.
Name of Sponsoring Organization(s):
