MindMed (NASDAQ:MNMD) has announced that the first patient has been dosed in its Phase 3 Voyage study of MM120, an orally disintegrating tablet (ODT) and pharmaceutically optimized form of LSD, in generalized anxiety disorder (GAD).
Voyage is the first-ever Phase 3 study of LSD, with the primary endpoint measuring the change from base line in the Hamilton Anxiety Rating Scale score at week 12 for MM120 ODT 100 µg compared to a placebo.
The first of two Phase 3 studies in GAD evaluating the efficacy and safety of MM120 ODT compared to a placebo, Voyage is expected to enroll approximately 200 patients in the U.S. A second Phase 3 trial, Panorama, will be conducted in the U.S. and Europe and is on track to initiate in the first half of 2025.
“Today marks a pivotal moment in our journey towards advancing a novel treatment option for the 20 million people in the U.S. living with GAD. Building on our scientifically rigorous Phase 2b study, which demonstrated efficacy that far exceeds today’s standard of care and a favorable tolerability profile, our Phase 3 studies are designed to adhere to the highest clinical and ethical standards and are in alignment with guidance from the FDA,” said Daniel R. Karlin, M.D., M.A., CMO of MindMed.
