Mind Medicine Inc. (NASDAQ: MNMD) experienced a 51.52% rise in its shares, reaching $9.00 after achieving regulatory approval, which represents a major accomplishment for the company.
MindMed (MNMD) disclosed that the FDA has granted breakthrough designation to its MM120 (lysergide d-tartrate) program intended for treatment of generalized anxiety disorder (GAD). Furthermore, the company reported positive results from its Phase 2b study of MM120 in GAD, meeting key secondary endpoints. The 12-week data demonstrated sustained activity observed through Week 12, both clinically and statistically significant.
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Earlier findings showed rapid and meaningful improvements on the Hamilton Anxiety rating scale (HAM-A) compared to a placebo at Week 4, the trial’s primary endpoint. Notably, MM120 exhibited robust efficacy, sustained for 12 weeks post a single dose, showcasing promising potential in anxiety treatment.
Acknowledging the substantial unmet medical need in GAD treatment, especially for patients resistant to or intolerant of existing medications, the FDA designated MM120 as a breakthrough therapy. MindMed intends to start a Phase 3 clinical program in the second half of 2024, after which it will hold an End-of-Phase 2 conference with the FDA in the first half of the same year.
The Phase 2b study’s durability statistics and the FDA’s classification of MM120 as a breakthrough medicine highlight the treatment’s potential to significantly address the unmet needs of people with GAD. In the Phase 2b study, known as MMED008, MM120 demonstrated good tolerability, with most adverse events being mild to moderate, transient, and occurring on dosing day, consistent with expected acute effects.
Before MM120 treatment, participants underwent clinical tapering and washout from any anxiolytic or antidepressant treatments and received no study-related psychotherapy during the study period. Primary data analyses from MMED008 are set for presentation at the American Psychiatric Association’s annual meeting in New York on May 4-8, 2024, and submission for publication in a leading medical journal is underway.
MindMed’s breakthrough designation for MM120 and the positive results from its Phase 2b study signifies a significant advancement in GAD treatment, offering hope to patients and healthcare professionals alike.
