FDA clears phase 2b study of LSD treatment for generalized anxiety

Clinical-stage biopharmaceutical company Mind Medicine Inc. announced the FDA cleared its investigational new drug application to proceed with a phase 2b dose-optimization of MM-120 for treating generalized anxiety disorder.

The treatment is a pharmacologically optimized form of LSD in development for generalized anxiety disorders and other brain-based disorders, the company said in a press release.

This decision follows a prior clinical hold on the IND, which was lifted after Mind Medicine, also known as MindMed, provided additional information on the participant monitoring protocol in the upcoming study. Participant enrollment is expected to begin in early 2022.

“FDA clearance of our phase 2b clinical trial represents a major milestone, for MindMed and for the industry as a whole,” Robert Barrow, CEO and director of MindMed, said in the release. “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. Further, the results of this trial will guide the dose selection and development strategy for our pivotal phase 3 clinical trials, as well as deepen our scientific understanding of the clinical effects of MM-120 and its underlying mechanisms of action.”