A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Panorama)

This Phase III, multicenter, randomised, double-blind, placebo-controlled trial (n=250) will evaluate the efficacy and safety of oral MM120 (LSD D-Tartrate) compared to placebo in adults diagnosed with generalized anxiety disorder (GAD). The study aims to assess changes in anxiety levels, primarily measured by the Hamilton Anxiety Rating Scale (HAM-A) total score, over a 12-week treatment period, followed by a 40-week open-label extension. Participants aged 18 to 74 years with a confirmed GAD diagnosis and a minimum HAM-A score of 20 will be enrolled. The trial consists of three arms: one receiving a placebo, one receiving 50 µg of MM120, and another receiving 100 µg of MM120. The initial 12-week phase will involve randomised, single-dose administration, after which participants will have the opportunity for open-label treatment based on safety and symptom severity criteria during the extension phase. The study is set to begin in January 2025 and aims to complete by May 2027.