Mind Medicine, a clinical-stage company focused on developing psychedelic-inspired drugs for the treatment of neuropsychiatric disorders, announces that the US Food and Drug Administration has approved its Investigational New Drug application for its lead product candidate, MM-120. The company’s clinical hold was lifted following the quick response it received from the FDA regarding the monitoring protocol for the study.
АMind Medicine is working with study sites and investigators to prepare for the enrollment of the first patient in the first quarter of 2022. The study MMED008, is a multicenter, dose-optimization trial designed to evaluate the effectiveness of MM-120 in patients with generalized anxiety disorder.
The approval of the Phase 2b trial for MindMed’s lead product candidate, MM-120, marks a major milestone for the company and the industry as a whole. It will allow MindMed to study the effects of the drug on patients with severe anxiety disorders. With the approval of this study, Mind Medicine aims to bring about a paradigm-shifting treatment for patients with severe anxiety disorders.