MindMed Advances MM120 for GAD with Phase 3 Trials Underway
• MindMed has initiated Phase 3 trials for MM120 ODT, a novel LSD-based treatment for generalized anxiety disorder (GAD).
• The Panorama study expands on the Voyage study by including a 50-microgram dose arm to mitigate functional unblinding bias.
• MM120 demonstrated rapid and sustained clinical response in Phase 2 trials, with significant improvements in anxiety reduction.
• The FDA has granted Breakthrough Therapy Designation for MM120, expediting regulatory review and development timelines.
MindMed's LSD Formulation MM120 Receives FDA Breakthrough Therapy Designation for Generalized Anxiety Disorder
• MindMed's MM120, a pharmaceutical-grade LSD formulation, has received Breakthrough Therapy Designation from the FDA for treating Generalized Anxiety Disorder (GAD).
• Clinical trials showed significant anxiety reduction in patients, with improvements more than double the standard of care, lasting weeks after a single dose.
• The FDA's designation allows MindMed to expedite the drug-approval process, acknowledging MM120's potential to address a serious unmet medical need.
• A larger Phase 3 clinical trial is planned to gather additional data on MM120's therapeutic effects, with safety monitoring protocols in place.
MindMed's MM120 Receives FDA Breakthrough Therapy Designation for Generalized Anxiety Disorder
• MindMed's MM120 (lysergide d-tartrate) has been granted Breakthrough Therapy designation by the FDA for the treatment of generalized anxiety disorder (GAD).
• A Phase 2b study showed a single dose of MM120 (100 μg) led to a 65% clinical response rate and a 48% clinical remission rate at 12 weeks.
• The study demonstrated clinically and statistically significant durability in HAM-A score reductions compared to placebo at 12 weeks post-administration.
• MindMed plans to meet with the FDA in early 2024 and initiate Phase 3 trials in the second half of 2024 to further evaluate MM120.
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