Mind Medicine, a late-stage clinical biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced that the first patient has been dosed in Panorama, its second Phase 3 study evaluating MM120 ODT, a proprietary, pharmaceutically optimized form of LSD for the treatment generalized anxiety disorder (GAD). The Panorama study will evaluate the efficacy and safety of MM120 ODT versus placebo, will be conducted in the United States and Europe, and is expected to enroll approximately 250 participants.
“This is an incredible time for MindMed, and we are optimistic about what lies ahead as we embark on our second Phase 3 study for MM120 ODT in GAD only weeks after the successful launch of our first Phase 3 study, Voyage,” said Dan Karlin, M.D., M.A., Chief Medical Officer of MindMed. “MM120 ODT represents a potentially life-changing treatment for people living with GAD, and if our Phase 3 development program is successful, it could offer a differentiated and compelling option for one of the most significant unmet needs in psychiatry. We aspire to deliver a truly transformational treatment that we believe has the potential to change the trajectory of the ongoing brain health epidemic.”
The clinical trial design of the 52-week Panorama study is aligned to Voyage and will be conducted in two parts: Part A, a 12-week, randomized, double-blind, placebo-controlled, parallel-group period; and Part B, a 40-week extension period during which participants will be eligible for open-label treatment with MM120 ODT based on symptom severity. Participants will be randomized 2:1:2 to receive MM120 ODT 100 µg, MM120 ODT 50 µg, or placebo. The 50 µg arm serves to confound participants’ ability to accurately assess the dose condition to which they have been randomized. This approach builds on the MM120 Phase 2b study, which the Company believes demonstrated that the clinical activity of MM120 was not attributable to functional unblinding and aligns with FDA guidance regarding the use of complementary designs across our Phase 2 and 3 studies. The primary endpoint of Panorama will measure the change from baseline in HAM-A at Week 12 between MM120 ODT 100 µg and placebo, which is consistent with the durable clinical effect observed in the MM120 Phase 2b study.
“GAD is a common and debilitating disorder, as we have shown that it impairs various cognitive abilities, and many patients are not sufficiently helped by currently available treatments. There is an urgent need for different approaches. The Panorama study builds on the results of MindMed’s Phase 2b study, which showed a rapid and sustained response to a single dose of MM120, demonstrating its potential as a promising treatment for GAD,” said Philip Gorwood, M.D., Ph.D., Professor of Psychiatry at Sainte-Anne Hospital and Paris Cité University, France. “Panorama, which is consistent with the design of the Phase 2b study, has the potential to be a transformative change in the way we understand and treat brain health disorders, offering acute but also lasting benefits to patients who have long been frustrated with current standards of care.”
