MindMed’s Phase 2b trial of MM120 in GAD achieved its key secondary endpoint, with 12-week topline data showing clinically and statistically significant durability of activity through Week 12. This showed how quickly clinically significant improvements on the Hamilton Anxiety Rating Scale (HAM-A) could occur and be sustained over a 12-week period after single oral administration of MM120 compared to placebo.
“Over two decades of clinical research studies in psychiatry has taught me a great deal. To see MM120 show rapid and robust efficacy that lasts 12 weeks after just one dose is truly amazing,” stated David Feifel, MD, PhD a Professor Emeritus of Psychiatry at the University of California San Diego as an investigator for its MM120 trial.
At Week 12, MM120 100 mg demonstrated an 8.2-point improvement over placebo with a clinical response rate of 68% and 48% clinical remission rate. These impressive figures not only demonstrate its efficacy, but also its rapid onset and long-term effectiveness – offering hope to those battling GAD.
FDA’s Breakthrough Designation and Next Steps
As recognition of MM120’s potential and unmet medical need in GAD treatment, the U.S. Food & Drug Administration (FDA) has granted it breakthrough therapy designation. This status is reserved for drugs which show substantial improvements over existing therapies during clinical trials and accelerate development and review processes.
MindMed plans to hold its End-of-Phase 2 meeting with the FDA during the first half of 2024 and launch their Phase 3 clinical program shortly thereafter, further emphasizing their dedication to fast tracking MM120’s availability for people living with GAD, with hopes of meeting their significant unmet need in this population.
Impact on Patients and Practitioners of Pharmaceutical Cost Increase
MM120 represents an exciting breakthrough for patients and healthcare practitioners alike. Its ability to deliver substantial reductions in anxiety symptoms through single dose therapy could transform treatment approaches, moving away from daily medication regimens towards more sustainable, long-term solutions.
“As both a clinician and clinical researcher, I commend MindMed for designing this study to isolate the effect of MM120 by eliminating confounding variables like additional medications or psychotherapy,” noted Reid Robison, MD, Psychiatrist and Chief Clinical Officer of Numinus. This meticulous approach to research provides confidence to its findings as well as potential benefits MM120 may bring patients.
MindMed’s development of MM120 promises to revolutionize treatment for Generalized Anxiety Disorder. Receiving both breakthrough therapy designation and promising clinical trial results, this breakthrough therapy shows promise as it could potentially provide long-lasting relief in just one dose. As MindMed moves toward Phase 3 trials, healthcare community and patients eagerly anticipate seeing this innovative therapy come to market – potentially providing relief to millions suffering from GAD.