FDA Grants Breakthrough Designation to MM-120 for Generalized Anxiety Disorder

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The US Food and Drug Administration has granted breakthrough designation to MindMed’s lysergide d-tartrate program (MM-120) for the treatment of generalized anxiety disorder (GAD). Additionally, MindMed released 12-week topline data showing its phase 2b study of MM-120 in GAD met its key secondary endpoint and had statistically significant durability of activity observed through week 12.¹

“I’ve conducted clinical research studies in psychiatry for over 2 decades and have seen studies of many drugs under development for the treatment of anxiety. That MM-120 exhibited rapid and robust efficacy, solidly sustained for 12 weeks after a single dose, is truly remarkable,” stated David Feifel, MD, PhD, professor emeritus of Psychiatry at the University of California, San Diego; director of the Kadima Neuropsychiatry Institute; and an investigator in the MM-120 study. “These results suggest the potential MM-120 has in the treatment of anxiety, and those of us who struggle every day to alleviate anxiety in our patients look forward to seeing results from future phase 3 trials.”

MMED008—a multi-center, parallel, randomized, double-blind, placebo-controlled, dose-optimization study—enrolled 198 participants who were randomly assigned to receive a 25, 50, 100, or 200 µg dose of MM-120, or placebo. Enrolled participants presented with severe GAD symptoms, measures as average baseline Hamilton Anxiety rating scale (HAM-A) scores of approximately 30. The main objective of the study was to evaluate the dose-response relationship of the 4 possible doses of MM-120 compared with placebo, measure by change in HAM-A from baseline to week 4.

The dose with optimal clinical activity was MM-120 100 µg, which demonstrated a 7.7 improvement over placebo at week 12 (-21.9 MM-120 vs -14.2 placebo; p<0.003 Cohen’s d=0.81), with a 65% clinical response rate and a 48% clinical remission rate sustained to week 12.

“As a clinician and clinical researcher, I applaud the way this study was designed by MindMed to isolate the effect of MM-120 by removing confounding variables like additional medications and psychotherapy,” said Reid Robison, MD, psychiatrist, chief clinical officer at Numinus, and investigator in the MM-120 study. “It gives me confidence in the data and the positive results give me hope that this may translate into meaningful benefits for my patients.”

Clinical Global Impressions - Severity (CGI-S) scores on average improved from 4.8 to 2.2 in the 100-µg dose group, representing a 2-category shift from ‘markedly ill’ to ‘borderline ill’ at week 12 (p<0.004). Clinical activity was observed as early as day 2, and lasted with further improvements in mean HAM-A or CGI-S scores between weeks 4 and 12.

“The FDA’s decision to designate MM-120 as a breakthrough therapy for GAD and the durability data from our phase 2b study provide further validation of the important potential role this treatment can play in addressing the huge unmet need among individuals living with GAD,” said Robert Barrow, Chief Executive Officer and Director of MindMed. “We are committed to bringing MM-120 to people living with GAD and delivering on the potential of our pipeline to treat serious brain health disorders.”

Another psychedelic has recently received FDA attention: the FDA recently accepted a new drug application for MDMA, intended for use in combination with psychological intervention for individuals with posttraumatic stress disorder.² Psilocybin also shows promise in alleviating symptoms of major depressive disorder.^3,4

References

1. MindMed receives FDA breakthrough therapy designation and announces positive 12-week durability data from phase 2b study of MM120 for generalized anxiety disorder. News release. March 7, 2024. https://ir.mindmed.co/news-events/press-releases/detail/137/mindmed-receives-fda-breakthrough-therapy-designation-and-announces-positive-12-week-durability-data-from-phase-2b-study-of-mm120-for-generalized-anxiety-disorder

2. O'Brien E. FDA accepts, grants priority review of NDA for MDMA-assisted therapy for PTSD. Psychiatric Times. February 13, 2024. https://www.psychiatrictimes.com/view/fda-accepts-grants-priority-review-of-nda-for-mdma-assisted-therapy-for-ptsd

3. O'Brien E. Study supports psilocybin as promising treatment for MDD. Psychiatric Times. August 31, 2023. https://www.psychiatrictimes.com/view/study-supports-psilocybin-as-promising-treatment-for-mdd

4. Miller B. Single-dose psilocybin for treatment-resistant major depression. Psychiatric Times. October 2, 2023. https://www.psychiatrictimes.com/view/single-dose-psilocybin-for-treatment-resistant-major-depression