MindMed Initiates Second Phase 3 Trial of Psychedelic MM120 for Generalized Anxiety Disorder

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Mind Medicine (MindMed), a late-stage clinical biopharmaceutical company, announced the initiation of Panorama, its second phase 3 clinical trial evaluating MM120 ODT, a proprietary formulation of lysergide D-tartrate (LSD), for the treatment of generalized anxiety disorder (GAD).¹

In a January 30, 2025, press release, the company announced that the first patient was dosed in the study, which builds on previous positive phase 2b results and is being conducted at sites in the US and Europe.¹

Panorama is a 52-week study with 2 parts: a 12-week, double-blind, placebo-controlled period (Part A) followed by a 40-week extension period (Part B) where participants may receive open-label treatment based on symptom severity. The study aims to enroll approximately 250 participants, who will be randomized 2:1:2 to receive MM120 ODT 100 µg, MM120 ODT 50 µg, or placebo. The 50-µg arm is intended to “confound participants’ ability to accurately assess the dose condition to which they have been randomized,” according to MindMed. This approach builds on data from the phase 2b study, which showed that the clinical activity of MM120 was not attributable to functional unblinding and aligns with FDA guidance on the use of complementary designs across both studies.¹

The study’s primary endpoint is the change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) score 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,” MindMed stated in the release.¹

The Phase 2b trial previously demonstrated that MM120 100 µg led to rapid, clinically meaningful, and statistically significant improvements on the HAM-A compared to placebo, with a 65% clinical response rate and 48% clinical remission rate sustained to week 12.²

“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,” Philip Gorwood, MD, PhD, Professor of Psychiatry at Sainte-Anne Hospital and Paris Cité University, France, said in the January 30 press release. “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.”¹

Panorama is part of MindMed’s broader MM120 phase 3 clinical development program, which also includes Voyage, a separate phase 3 study for GAD, and Emerge, an ongoing study for major depressive disorder (MDD).¹

MM120 incorporates Catalent’s Zydis ODT fast-dissolve technology, meaning a more rapid absorption, improved bioavailability, and reduced gastrointestinal side effects. The agent is a synthetic ergotamine, which acts as a partial agonist at human serotonin-2A (5-HT_2A) receptors. The FDA granted MM120 a Breakthrough Therapy Designation for GAD in March 2024.^1,2

Topline results from Panorama’s 12-week double-blind period are expected in the second half of 2026, according to MindMed.¹

References:

1. MindMed announces first patient dosed in Panorama, the second pivotal phase 3 study of MM120 in generalized anxiety disorder. News release. MindMed Inc. January 30, 2025. Accessed February 4, 2025. https://ir.mindmed.co/news-events/press-releases/detail/171/mindmed-announces-first-patient-dosed-in-panorama-the-second-pivotal-phase-3-study-of-mm120-in-generalized-anxiety-disorder
2. MindMed receives FDA Breakthrough Therapy Designation and announces positive 12-week durability data from phase 2b study of MM120 for generalized anxiety disorder. News release. MindMed Inc. March 7, 2024. Accessed February 4, 2025. https://ir.mindmed.co/news-events/press-releases/detail/137/mindmed-receives-fda-breakthrough-therapy-designation-and-announces-positive-12-week-durability-data-from-phase-2b-study-of-mm120-for-generalized-anxiety-disorder