MindMed Inc. has announced the dosing of the first patient in its phase 3 Voyage study of MM120 ODT, a pharmaceutically optimized form of lysergide d-tartrate (LSD) for the treatment of Generalized Anxiety Disorder (GAD). The study is the first-ever phase 3 study of LSD with the primary endpoint measuring the change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) score at week 12 for MM120 ODT 100 µg versus placebo.
The Voyage study is expected to enroll approximately 200 participants in the United States and will be conducted in two parts: a 12-week, randomized, double-blind, placebo-controlled, parallel group period and a 40-week extension period. The primary endpoint will measure the change from baseline in HAM-A at week 12, consistent with the durable clinical effect observed in the phase 2b study.
The company's phase 2b study, MMed008, demonstrated rapid, clinically meaningful, and statistically significant improvements on the HAM-A at week 4 and week 12, with a 65% clinical response rate and 48% clinical remission rate sustained to week 12 in the MM120 100 µg cohort. MM120 was generally well-tolerated in this study, with most adverse events rated as mild to moderate, transient, and occurring on the dosing day.
The U.S. Food & Drug Administration (FDA) has granted breakthrough therapy designation (BTD) for the MM120 program in GAD based on the significant unmet medical need in the treatment of GAD along with the initial clinical data from the phase 2b study and other research conducted by MindMed.
The company also mentioned that the second phase 3 trial, the Panorama study, will be conducted in the U.S. and Europe and is on track to initiate in the first half of 2025.
It's worth noting that GAD is a common condition associated with significant impairment that affects approximately 10% of U.S. adults, representing around 20 million people. Despite the significant personal and societal burden of GAD, there has been little innovation in its treatment in the past several decades, with the last new drug approval occurring in 2007. The market has reacted to these announcements by moving the company's shares 4.9% to a price of $7.51. For more information, read the company's full 8-K submission here.
