MindMed achieves positive topline results in phase 2b clinical trial
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Key takeaways:
- MM-120 demonstrated a statistically significant dose-dependent improvement in HAM-A scores.
- The anxiety treatment was generally well-tolerated, with mostly mild to moderate adverse events on dosing day.
MindMed has announced positive topline results from its phase 2b clinical trial of MM-120 in generalized anxiety disorder, according to a company press release.
The trial met its primary endpoint, with MM-120 (lysergide D-tartrate) demonstrating a “statistically significant” dose-dependent improvement on the Hamilton Anxiety rating scale (HAM-A) compared with placebo at 4 weeks, according to the release.
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“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,” MindMed Director and CEO Robert Barrow said in the release. “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.”
In addition, MM-120 was generally well-tolerated, with mostly mild to moderate adverse events occurring on dosing day, according to the release.
The company plans to hold an End-of-Phase 2 meeting with the FDA in the first half of 2024. Phase 3 clinical trials are expected to begin in the second half of 2024.