NEW YORK - Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), a clinical stage biopharmaceutical company, has announced that its experimental drug MM120 has achieved a breakthrough therapy designation from the U.S. Food & Drug Administration (FDA) for the treatment of generalized anxiety disorder (GAD). This follows the success of the drug in meeting its key secondary endpoint in a Phase 2b study.
The study showed that a single dose of MM120 led to clinically and statistically significant reductions in anxiety symptoms, sustained over a 12-week period. The results demonstrated a 65% clinical response rate and a 48% clinical remission rate at the end of this period. The drug was administered once in a clinical setting without additional therapeutic intervention.
MM120, at a 100 µg dose, resulted in a 7.7-point improvement over placebo at the 12-week mark. The Clinical Global Impressions - Severity scores also improved significantly, indicating a shift from 'markedly ill' to 'borderline ill' in patients.
The FDA's breakthrough therapy designation is granted to expedite the development and review of drugs intended to treat serious conditions when preliminary clinical evidence indicates the drug may demonstrate substantial improvement over available therapy.
MindMed is planning an End-of-Phase 2 meeting with the FDA in the first half of 2024 and aims to initiate a Phase 3 clinical program in the latter half of the year. The Phase 2b study, known as MMED008, involved 198 participants who received either MM120 or a placebo. The drug was generally well-tolerated, with most adverse events being mild to moderate and transient.
The primary data analyses from the MMED008 study will be presented at the American Psychiatric Association’s annual meeting scheduled for May 4-8, 2024, and is also being submitted for publication in a leading medical journal.
GAD is a prevalent condition affecting approximately 20 million adults in the U.S. alone, characterized by excessive, persistent worry. Despite the high personal and societal impact, the last new drug approval for GAD was in 2004, highlighting the need for new treatments.
MindMed's MM120 is a synthetic ergotamine and part of the serotonergic psychedelics that act on serotonin receptors. The company is exploring its potential applications for GAD and other serious brain health disorders.
This news is based on a press release statement from Mind Medicine (MindMed) Inc.
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