MindMed will now move forward with the 200 patient randomized, placebo-controlled study.
The US Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application allowing MindMed to move forward with a phase 2b dose-optimization trial of MM-120 for the treatment of generalized anxiety disorder (GAD).
The proprietary drug candidate is a pharmacologically optimized form of Lysergic acid diethylamide (LSD) being studied for GAD and other brain-based disorders.
The study is designed to be a multicenter, randomized, double-blind, placebo-controlled, dose-optimization trial for adult patients with GAD. The study organizers are planning to enroll 200 participants who will receive a single administration of up to 200 µg of MM-120 or a placebo.
The investigators will determine the reduction in anxiety symptoms for up to 12 weeks following treatment, compared across 5 treatment arms.
Previously there was a clinical hold on the application after the agency requested additional information related to the participant monitoring protocols in the upcoming study.
MindMed is also working with investigators and clinical trial sites to prepare for participant enrollment, set to begin in 2022.
"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,” said Robert Barrow, Chief Executive Officer and Director of MindMed, in a statement. “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."