MindMed Begins Phase 3 Emerge Study of MM120 in Patients With Major Depressive Disorder

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MindMed recently announced that the first patient has been dosed in its phase 3 Emerge study evaluating MM120 ODT for treatment of major depressive disorder (MDD). MM120 ODT is a proprietary, pharmaceutically optimized form of lysergic acid diethylamide (LSD). MindMed will also test the efficacy and safety of MM120 ODT 100 µg compared with a placebo, with an expected enrollment of approximately 140 participants in the United States.¹

The company’s past trials, Voyage and Panorama, found that 100 µg of MM120 ODT was the optimal dose, resulting in strong efficacy, durability, and an acceptable safety profile, as well as less prolonged adverse effect burden associated with daily medications for patients with generalized anxiety disorder (GAD).² Emerge is the third phase 3 study of MM120 ODT conducted by MindMed.

Further results from the 2 studies provided 3 major advantages over existing treatments for GAD, which primarily includes selective serotonin reuptake inhibitors (SSRIs) and benzodiazepines. Researchers found that MM120 acts rapidly, with anxiety being reduced within a day compared with weeks required with SSRIs. They also found a single dose of MM120 has long-lasting effects of up to 12 weeks, with phase 3 trials extending follow-up to a year. Lastly, results showed the magnitude of improvement was significantly greater than that seen in traditional treatments, with an effect size of 0.7 to 0.8 compared with 0.3 for SSRIs.

With 2 successful trials, MindMed is currently recruiting more participants for both Voyage and Panorama, positioning MM120 as a potential break-through treatment in GAD and MMD.

“In our phase 2b study, MADRS score improvements after a single MM120 100 µg dose were clinically and statistically significant compared to placebo, providing meaningful benefits to participants,” said Daniel R. Karlin, MD, MA, chief medical officer of MindMed. “Having dosed the first participant in the phase 3 Emerge study, we are excited for the therapeutic potential that MM120 ODT shows for the 21 million people in the US affected by MDD. By running our MDD and GAD phase 3 studies concurrently, we can leverage the shared symptomatology between these conditions to more effectively match participants to the appropriate study based on their clinical presentation.”¹

MindMed’s phase 3 development program for MM120 ODT in patients with MDD is projected to have 2 clinical trials. The first trial is the 52-week Emerge study, which will consist of 2 parts. Part A will be a 12-week, randomized, double-blind, placebo-controlled, parallel-group study testing the efficacy and safety of a single dose of MM120 ODT compared with placebo. Next, Part B will be a 40-week extension period where participants will be eligible for open-label treatment with MM120 ODT based on symptom severity.

"The initiation of Emerge will allow the assessment of the potential of MM120 ODT in the treatment of MDD, a disorder associated with significant increased and premature morbidity and mortality, and reduced quality of life. Many patients with MDD are not fully helped by current therapies, making this study an important step in the search for more effective treatments,” said Paul Summergrad, MD, professor of psychiatry and medicine at Tufts University School of Medicine, chairman emeritus of the department of psychiatry at Tufts Medical Center, and a member of the MindMed Scientific Advisory Board.

The main goal of the Emerge study is to explore the change from baseline in MADRS score at week 6 between MM120 ODT 100 µg and placebo. The second MDD trial will depend on the progress from Emerge and further regulatory discussions. Topline data from Part A of the study is expected to be released in the second half of 2026.

References

1. MindMed announces first patient dosed in phase 3 Emerge study of MM120 in major depressive disorder (MDD). News release. April 15, 2025. Accessed April 21, 2025. https://www.businesswire.com/news/home/20250414503827/en/MindMed-Announces-First-Patient-Dosed-in-Phase-3-Emerge-Study-of-MM120-in-Major-Depressive-Disorder-MDD

2. Karlin D. MM120 shows rapid and lasting anxiety reduction in phase 3 generalized anxiety disorder trials. Psychiatric Times. February 14, 2025. Accessed April 21, 2025. https://www.psychiatrictimes.com/view/mm120-shows-rapid-and-lasting-anxiety-reduction-in-phase-3-gad-trials