Mind Medicine (MindMed) Inc. , a clinical-stage biopharmaceutical company developing psychedelic-inspired therapies for the treatment of brain-based disorders, announced today that the U.S. Food and Drug Administration (FDA) has cleared MindMed's Investigational New Drug (IND) application, allowing the Company's Phase 2b dose-optimization trial of MM-120 for the treatment of generalized anxiety disorder (GAD) to proceed.

The previously announced clinical hold on the IND was lifted following MindMed's rapid responses for additional information related to the participant monitoring protocol in the upcoming study. The Company is working with study investigators and clinical trial sites to prepare for participant enrollment, which is expected to start in early 2022.

"FDA clearance of our Phase 2b clinical trial represents a major milestone, for MindMed and for the industry as a whole," said Robert Barrow, Chief Executive Officer and Director of MindMed. "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."

Mr. Barrow continued, "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."