Mind Medicine (MindMed) Inc (NASDAQ: MNMD) has announced the dosing of the first patient in the Phase 2b dose-optimization study of MM-120 for Generalized Anxiety Disorder (GAD) treatment. MM-120 is a pharmaceutically enhanced version of LSD (lysergic acid diethylamide).
Phase 2b findings to inform dose determination
CEO of MindMed Robert Barrow, “The initiation of our Phase 2b clinical trial, the largest well-controlled clinical trial of LSD ever conducted, represents a major milestone for MindMed and for the many patients suffering from GAD. This exciting next step in the advancement of LSD builds on the positive topline data presented by our partners at University Hospital Basel in May 2022, which demonstrated the rapid, durable, and statistically significant effects of LSD and its potential to safely mitigate symptoms of anxiety and depression.”
The Phase 2b study findings will inform the dose determination and development approach for the crucial third-phase clinical studies. In addition, the company continues to work to find a new possible treatment for millions of GAD patients.
Notably the Phase 2b study in GAD patients is a randomized, multicentre, placebo-controlled, double-blind, parallel, dose-optimization trial. The company will enroll around 200 subjects, with each receiving a single 200µg dose of MM-120 or placebo. The main goal is to assess the improvement in generalized anxiety symptoms in each of the five treatment cohorts four weeks following a single dose of MM-120. Key secondary goals include evaluating the quality of life, safety, and tolerability, which are examined up to twelve weeks following the single dosage.
GAD affects around 6% of Americans
Roughly 6% of Americans will experience GAD at some point in their lives. It is a persistent, frequently crippling mental health disease. National Institute of Mental Health indicates that excessive anxiety and concern that lasts for more than six months are signs of GAD and therefore can cause serious problems with social, vocational, and other functions. Although Major Depressive Disorder (MDD), GAD, and other major psychological diseases have a lot of diagnostic similarities, there hasn’t been much advancement in GAD therapy over the previous few decades.