NEW YORK–(BUSINESS WIRE)– Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (the “Company” or “MindMed”), a late-stage clinical biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced that the first patient has been dosed in its Phase 3 Emerge study evaluating MM120 ODT, a proprietary, pharmaceutically optimized form of LSD for the treatment of MDD. Emerge will evaluate the efficacy and safety of MM120 ODT 100 µg versus placebo and is expected to enroll approximately 140 participants in the United States. Emerge is the third Phase 3 study of MM120 ODT, with the Voyage and Panorama studies in GAD already underway.
“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. 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 U.S. affected by MDD,” said Daniel R. Karlin, M.D., M.A., Chief Medical Officer of MindMed. “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.”
The Phase 3 development program for MM120 ODT in MDD is anticipated to include two pivotal clinical trials. The first, the 52-week Emerge study, will be conducted in two parts: Part A, a 12-week, randomized, double-blind, placebo-controlled, parallel-group study assessing the efficacy and safety of a single dose of MM120 ODT versus placebo; and Part B, a 40-week extension period during which participants will be eligible for open-label treatment with MM120 ODT based on symptom severity. In Part A, participants will be randomized 1:1 to receive MM120 ODT 100 µg or placebo. The primary endpoint of Emerge is the change from baseline in MADRS score at week 6 between MM120 ODT 100 µg and placebo. The design and timing of a second MDD trial will be informed by the progress from Emerge and additional regulatory discussions.
“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, M.D., Professor of Psychiatry and Medicine at Tufts University School of Medicine and Chairman Emeritus of the department of psychiatry at Tufts Medical Center and a member of the MindMed Scientific Advisory Board.
About Major Depressive Disorder (MDD)
Major Depressive Disorder (MDD) is the second-most common mental health disorder in the U.S., with over 21 million adults experiencing a major depressive episode (MDE) each year.1,2 This disorder, a leading cause of disability worldwide,3 brings persistent feelings of worthlessness, fatigue, and recurrent thoughts of death4 while increasing long-term mortality risk by 40%.5 MDD also carries a $326 billion annual economic burden in the U.S., driven by healthcare costs and lost productivity.6 Yet, fewer than half of those affected receive adequate pharmacotherapy, and only about one-third achieve remission with first-line treatments.7,8
About MM120 Orally Disintegrating Tablet (ODT)
MM120 ODT (lysergide D-tartrate or LSD) is a synthetic ergotamine belonging to the group of classic, or serotonergic, psychedelics, which acts as a partial agonist at human serotonin-2A (5-HT2A) receptors. MM120 ODT is MindMed’s proprietary and pharmaceutically optimized form of LSD. MM120 ODT is an advanced formulation incorporating Catalent’s Zydis® ODT fast-dissolve technology which has a unique clinical profile with more rapid absorption, improved bioavailability and reduced gastrointestinal side effects.
The MM120 ODT Phase 3 clinical development program includes the Voyage and Panaroma studies in generalized anxiety disorder (GAD) and the Emerge study in major depressive disorder (MDD). Additional clinical indications are under consideration. MindMed’s Phase 2b study of MM120 for GAD, MMED008, met its primary and key secondary endpoints and demonstrated rapid, clinically meaningful, and statistically significant improvements on the Hamilton Anxiety Rating Scale (HAM-A) at Week 4 and Week 12, with a 65% clinical response rate and 48% clinical remission rate sustained to Week 12 in the MM120 100 µg cohort. Results from the assessment of several additional secondary endpoints were pre-specified, including the change from baseline compared to placebo in Montgomery-Åsberg Depression Rating Scale (MADRS) scores, which measure the severity of depression symptoms. MDD and depressive symptoms are common co-morbidities in people with GAD. MADRS score improvements in the 100 µg arm of the study were clinically and statistically significant compared to the placebo group, with a difference of 5.7 points (p≤0.05) at week 4 and a difference of 6.4 points (p≤0.05) at 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 and being consistent with the expected acute effects of the trial drug.
Based on the significant unmet medical need in the treatment of GAD along with the initial clinical data from the Phase 2b study and other research conducted by MindMed, the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation for the MM120 program in GAD. MindMed has also been granted an Innovation Passport for the potential treatment of GAD under the United Kingdom Innovative Licensing and Access Pathway (ILAP) by the U.K. Medicines and Healthcare products Regulatory Agency. The Innovation Passport is the entry point to the ILAP, which aims to accelerate time to market and facilitate patient access to medicines in the U.K.
MindMed is a late-stage clinical biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health. MindMed trades on NASDAQ under the symbol MNMD.