Mind Medicine (MindMed) (NASDAQ:MNMD), a biopharmaceutical company focused on developing treatments for brain health disorders, announced today the initiation of its Phase 3 Emerge study.
The trial will evaluate the efficacy and safety of MM120 ODT, a proprietary, optimized form of lysergic acid diethylamide (LSD), for the treatment of major depressive disorder (MDD).
The first patient has been dosed in the Emerge study, which aims to enroll approximately 140 participants across the United States. This pivotal Phase 3 trial will compare a single 100 µg dose of MM120 ODT against a placebo.
The Emerge study is structured in two parts.
Part A is a 12-week, randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of the single dose.
Participants will be randomly assigned in a 1:1 ratio to receive either MM120 ODT 100 µg or a placebo.
The primary goal of Part A is to measure the change from the start of the study (baseline) in the Montgomery-Åsberg Depression Rating Scale (MADRS) score at week 6.
Following the initial 12 weeks, Part B will be a 40-week extension period where participants can receive open-label treatment with MM120 ODT based on the severity of their symptoms.
Emerge is the third Phase 3 study in MindMed's MM120 ODT development program.
The company already has two Phase 3 studies, Voyage and Panorama, underway evaluating the drug for generalized anxiety disorder (GAD).
The development program for MM120 ODT in MDD is anticipated to include two pivotal clinical trials.
The design and timeline of the second MDD trial will be determined based on the progress of the Emerge study and further discussions with regulatory authorities.
Meanwhile, MindMed's decision to advance MM120 ODT into Phase 3 for MDD is supported by positive results from a Phase 2b study in GAD, which indicated potential antidepressant effects of the drug.
Topline data from the 12-week double-blind portion of the Emerge study is expected in the second half of 2026.