Mind Medicine (MindMed (NASDAQ:MNMD, NEO:MMED)) has announced encouraging results from its Phase 2b clinical trial of MM-120 in treating Generalized Anxiety Disorder (GAD). MM-120, a single-dose lysergide d-tartrate, demonstrated statistically significant and clinically meaningful improvements over placebo at Week 4, meeting its primary endpoint.
In the trial, MM-120 100 µg - the dose achieving the highest level of clinical activity - demonstrated a 7.6-point reduction on the Hamilton Anxiety rating scale (HAM-A) compared to placebo at Week 4. The Clinical Global Impressions - Severity (CGI-S) scores also improved significantly, shifting from 'markedly ill' to 'borderline ill' in the 100 µg dose group.
“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 CEO Robert Barrow said in a statement.
"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.”
Additional study results, including topline 12-week data in Q1 2024, are expected in the coming months, Barrow added.
"Few new treatment options have shown robust activity in GAD since the last new drug approval in 2004, making the strong, rapid, and durable clinical activity of a single dose of MM-120 observed in the trial particularly notable," said MindMed chief medical officer Daniel Karlin.
"We believe this study is the first to rigorously assess the efficacy of a drug candidate in this class in the absence of a concurrent therapeutic intervention, which brings hope to the millions of people suffering from GAD and provides additional evidence that MM-120 may play an important role in revolutionizing the treatment of brain health disorders.”
Secondary and exploratory endpoints, including HAM-A response and remission rates, and CGI-S scores, further supported MM-120's efficacy. Participants treated with MM-120 (100 µg or 200 µg) demonstrated a 78% clinical response at Week 4, compared to 31% for placebo. Moreover, MM-120 was generally well-tolerated, with mostly transient mild-to-moderate adverse events consistent with its pharmacodynamic effects.
With a completion rate of approximately 90% in the trial and no high-dose group discontinuations due to adverse events, MindMed said it is optimistic about advancing MM-120 into Phase 3 development for GAD, potentially offering a groundbreaking solution to address the pressing needs of this patient population.
MindMed's shares were up 3% at $0.017 in early Thursday morning trade in New York.