MindMed is making significant strides in the development of MM120 ODT, a proprietary, pharmaceutically optimized form of lysergide D-tartrate (LSD), as a potential treatment for generalized anxiety disorder (GAD). With two Phase 3 clinical trials underway, Voyage and Panorama, MindMed aims to address the unmet needs of the 20 million people in the U.S. living with GAD.
Phase 3 Trials: Voyage and Panorama
The Voyage study, the first-ever Phase 3 trial of LSD for any medical condition, is a 52-week study conducted in two parts. Part A involves a 12-week, randomized, double-blind, placebo-controlled, parallel-group period, while Part B is a 40-week extension period during which participants may receive open-label treatment with MM120 ODT based on symptom severity. The primary endpoint of Voyage is the change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) score at Week 12.
Building on the Voyage study, the Panorama trial expands the research to include sites in both the U.S. and Europe. A key difference in the Panorama trial is the inclusion of a 50 μg dose arm, in addition to the 100 μg dose and placebo arms. This is designed to address concerns about functional unblinding, where participants may deduce their treatment group based on perceptual effects. According to MindMed's chief medical officer, Daniel R. Karlin, MD, MA, the 50 μg dose group aims to "confound the understanding of folks in the active arm...and in the placebo arm, as to what they received, and to create that uncertainty...to further reinforce our understanding of measured drug effect being actual drug effect."
MM120: A Potential Game-Changer for GAD Treatment
MM120 ODT leverages Catalent's Zydis ODT fast-dissolve technology, which offers rapid absorption, improved bioavailability, and reduced gastrointestinal side effects. It acts as a partial agonist at human serotonin-2A (5-HT2A) receptors. The FDA has granted Breakthrough Therapy Designation for the MM120 program in GAD, highlighting its potential to significantly improve treatment options.
"MM120 ODT represents a potentially life-changing treatment for people living with GAD, and if our Phase 3 development program is successful, it could offer a differentiated and compelling option for one of the most significant unmet needs in psychiatry," said Dan Karlin, M.D., M.A., Chief Medical Officer of MindMed.
Clinical Efficacy and Safety
MindMed's Phase 2b study, MMED008, demonstrated rapid, clinically meaningful, and statistically significant improvements on the Hamilton Anxiety Rating Scale (HAM-A) at Week 4 and Week 12. The MM120 100 μg cohort showed a 65% clinical response rate and a 48% clinical remission rate sustained to Week 12. MM120 was generally well-tolerated in this study, with most adverse events rated as mild to moderate, transient, and occurring on the dosing day, consistent with the expected acute effects of the trial drug.
Addressing Unmet Needs in GAD Treatment
Generalized Anxiety Disorder (GAD) affects approximately 10% of U.S. adults, representing around 20 million people. It is characterized by excessive, persistent, and unrealistic worry about everyday things, leading to significant impairment and reduced labor force participation. Despite the significant personal and societal burden of GAD, there has been little innovation in its treatment over the past several decades.
Existing GAD treatments, including benzodiazepines, buspirone, and selective serotonin reuptake inhibitors (SSRIs), often require daily use, multiple medication switches, and may not be effective for all patients. The last FDA-approved treatment for GAD dates back to 2007, underscoring the urgent need for new therapeutic options.
MM120 presents several potential advantages over existing GAD treatments. It acts rapidly, with anxiety reductions observed within a day, compared to the weeks required for SSRIs. A single dose has shown long-lasting effects up to 12 weeks, and the magnitude of improvement is significantly greater than that seen with traditional treatments, with an effect size of 0.7 to 0.8 compared to 0.3 for SSRIs.
Looking Ahead
Topline data from the 12-week double-blind period of the Panorama study is anticipated in the second half of 2026. If the Phase 3 development program is successful, MM120 ODT could offer a differentiated and compelling treatment option for GAD, potentially changing the trajectory of the ongoing brain health epidemic.
