FDA Clears the Way for First Commercial Study of LSD in 40 Years

Jan 25, 2022 By MarketDepth

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FDA Approval

Mind Medicine Inc. (NASDAQ: MNMD) has seen its Investigational New Drug application cleared by the FDA, opening the door for the company’s Phase 2b dose-optimization trial of MM-120 for the treatment of generalized anxiety disorder to proceed.

Up Premarket

Shares of Mind Medicine Inc. (NASDAQ: MNMD) gained over 8% during the pre-market session.

FDA Clearance

MM-120 is the company’s proprietary drug candidate and pharmacologically optimized form of LSD being developed for various brain-based disorders. The FDA clearance comes after the company satisfied requests for additional information related to the participant monitoring protocol in the upcoming study.

“FDA clearance of our Phase 2b clinical trials represents a major milestone, for MindMed and for the industry as a whole.”

Robert Barrow, Chief Executive Officer and Director of MindMed

The company is now collaborating with study investigators as well as clinical trial sites in an effort to prepare for enrollment in the early stages of 2022. A total of 200 participants will receive a single administration of up to 200 µg of MM-120 or a placebo control, with the reduction in anxiety symptoms a primary objective of the study.

“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.”

Robert Barrow, Chief Executive Officer and Director of MindMed