FDA Breakthrough Therapy Designation and the Future of MM120

MindMed’s Chief Medical Officer, Dan Carlin, MD, MA, spoke with Psychiatric Times about the second phase 3 trial, Panorama (MM-120-301), for MM-120 in generalized anxiety disorder (GAD). This follows the ongoing first phase 3 trial, Voyage (MM-120-300), marking a significant milestone in the study of MM-120, a novel LSD-based treatment for GAD.

Voyage, initiated in late 2024, is a 2-arm, double-blind, placebo-controlled study conducted across nearly 30 sites in the US. It evaluates a 100-microgram dose of MM-120 against placebo, measuring changes in Hamilton Anxiety Rating Scale scores over 12 weeks. Panorama, launched in early 2025, expands the study internationally, involving 35 sites with approximately 66% in the EU and 33% in the U.S. Unlike Voyage, Panorama includes an additional 50-microgram dose group to assess the role of functional blinding and expectancy effects.

The introduction of the 50-microgram arm aims to address concerns surrounding participant awareness of dosing groups, ensuring that the observed effects are drug-related rather than influenced by placebo responses. This methodological approach strengthens the reliability of MindMed’s research findings.

MindMed has received Breakthrough Therapy designation from the US Food and Drug Administration (FDA), recognizing MM-120’s potential to significantly improve treatment options for GAD. This designation facilitates enhanced collaboration with the FDA, expediting regulatory review and development timelines.

Looking ahead, MindMed plans to launch a Phase 3 trial for major depressive disorder in the first half of 2025, with additional studies expected. Readouts for Voyage and Panorama are anticipated in 2026, with findings poised to shape the future of psychiatric treatment. As MM-120 progresses towards FDA approval, MindMed encourages clinicians and researchers to engage with the evolving treatment landscape.

Dr Karlin is the chief medical officer of MindMed and a fellow of the APA.