NEW YORK, NY, December 18, 2023 – Biopharmaceutical company, Mind Medicine (Nasdaq: MNMD) has announced positive results from its Phase 2b clinical trial of MM-120 (lysergide d-tartrate) in generalized anxiety disorder (GAD). The trial met its primary endpoint, with MM-120 demonstrating statistically significant and clinically meaningful dose-dependent improvements.
Robert Barrow, Chief Executive Officer and Director of MindMed, said, “We are excited by the strong positive results for MM-120 in GAD, particularly given that this is the first study to assess the standalone drug effects of MM-120 in the absence of any psychotherapeutic intervention. These promising findings represent a major step forward in our goal to bring a paradigm-shifting treatment to the millions of patients who are profoundly impacted by GAD.”
MindMed expects to initiate Phase 3 clinical trials in the second half of 2024.
Study MMED008 is a multi-center, parallel, randomized, double-blind, placebo-controlled, dose-optimization study. The trial enrolled 198 participants.
MM-120 demonstrated statistically significant and clinically meaningful dose-dependent improvements on the Hamilton Anxiety rating scale (HAM-A) compared to placebo at Week 4. MM-120 was administered as a single-dose in a monitored clinical setting with no additional therapeutic intervention.
Clinical activity was observed to be rapid and durable, beginning on Day 2 and continuing through Week 4 with no loss of activity observed on either HAM-A or CGI-S. MM-120 was generally observed to be well tolerated.
MindMed expects to share additional study results in the coming months, including topline 12-week results in the first quarter of 2024, and will be working closely with FDA to finalize the Phase 3 development program for MM-120 in GAD.
GAD is a brain health disorder that results in fear, persistent anxiety and a constant feeling of being overwhelmed. It is characterized by excessive, persistent, and unrealistic worry about everyday things.
MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health disorders.
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