Mind Medicine (MindMed) Inc. has recently announced the commencement of its second pivotal phase 3 study, Panorama, to evaluate MM120 ODT, a proprietary form of LSD, in the treatment of Generalized Anxiety Disorder (GAD). The study aims to assess the efficacy and safety of MM120 ODT compared to a placebo and is expected to enroll approximately 250 participants in the United States and Europe.
The Panorama study is designed to be conducted in two parts: a 12-week, randomized, double-blind, placebo-controlled, parallel-group period (Part A), and a 40-week extension period (Part B). Participants will be randomized to receive MM120 ODT 100 µg, MM120 ODT 50 µg, or a placebo. The primary endpoint of the study will measure the change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) at week 12 between MM120 ODT 100 µg and the placebo.
The company's Chief Medical Officer, Dan Karlin, M.D., M.A., expressed optimism about the potential of MM120 ODT in treating GAD, citing the successful launch of the first phase 3 study, Voyage. The Phase 2b study demonstrated a rapid and sustained response to a single dose of MM120, indicating its potential as a promising treatment for GAD.
According to the press release, approximately 10% of U.S. adults, representing around 20 million people, currently suffer from GAD. Despite the significant personal and societal burden of GAD, there has been little innovation in its treatment in recent decades, with the last new drug approval occurring in 2007.
The MM120 ODT Phase 3 clinical development program includes the Voyage and Panorama studies in GAD, as well as the Emerge study in Major Depressive Disorder (MDD). The company's Phase 2b study, MMed008, met its primary and key secondary endpoints, demonstrating rapid, clinically meaningful, and statistically significant improvements on the HAM-A scale 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. The study also indicated that MM120 was generally well-tolerated.
MindMed has been granted breakthrough therapy designation for the MM120 program in GAD by the U.S. Food and Drug Administration, along with an innovation passport for potential treatment of GAD under the United Kingdom Innovative Licensing and Access Pathway (ILAP) by the U.K. Medicines and Healthcare Products Regulatory Agency.
Today the company's shares have moved -3.1% to a price of $7.09. If you want to know more, read the company's complete 8-K report here.
