Mind Medicine Inc. (NASDAQ: MNMD) has announced that the US FDA has approved its Investigational New Drug application that allows the company to proceed with its Phase 2b dose-optimization study of MM-120 for generalized anxiety disorder treatment.
MedMen to continue MM-120 dose-optimization trial
Following MindMed’s prompt responses for more information pertaining to the participant tracking methodology in the upcoming trial, the FDA lifted the previously announced clinical hold on the IND. As a result, the company is collaborating with research investigators and clinical study locations to plan for participant enrolment, which will begin in early 2022.
CEO and Director Robert Barrow stated, “FDA clearance of our Phase 2b clinical trial represents a major milestone, for MindMed and for the industry as a whole. This trial, the first commercial study of LSD in more than 40 years, builds on productive discussions with FDA and provides an opportunity to explore improvements in anxiety symptoms following a single administration of MM-120.”
Notable, the findings of this study will inform the dose determination and development approach for the critical Phase II clinical studies and the advancement of scientific understanding of MM-120’s clinical benefits and fundamental modes of action.
“With a clear regulatory path, we look forward to building on this momentum and advancing this trial as quickly and efficiently as possible, bringing us significantly closer to transforming the treatment landscape for patients who suffer from anxiety,” added Barrow.
MMED008 is a dose-optimization study in GAD subjects
MMED008 is a dose-determination Phase 2b study in GAD patients that is randomized, double-blind, multicenter, and placebo-controlled. A sample of 200 people will be enrolled in the study, who will be given either a single dose of up to 200g of MM-120 or a placebo. The study’s primary goal is to compare the improvement in anxiety feelings for around twelve weeks after one single MM-120 injection over five treatment groups.
MM-120, a pharmaceutically refined version of LSD being investigated for GAD and other neurological illnesses, is MindMed’s patented medication candidate. In addition, it has been evaluated for use in anxiety related to terminal cancer, opioid use disorder, depression, and alcoholism.
