MindMed Presents Promising Phase 2b Results for Novel GAD Treatment

MindMed Inc. (NASDAQ: MNMD) presented data from its Phase 2b study of MM120, a novel treatment for Generalized Anxiety Disorder (GAD), at the American Psychiatric Association (APA) Annual Meeting in New York City. The study demonstrated clinically and statistically significant efficacy compared to placebo at 12 weeks, with a 65% clinical response rate and a 48% clinical remission rate.

The Phase 2b study, MMED008, met its primary and key secondary endpoints, showing rapid and durable improvements in anxiety symptoms. MM120 was administered as a single dose in a monitored clinical setting with no additional therapeutic intervention. The primary endpoint was measured at Week 4, and the secondary endpoint at Week 12.

Why this matters: The development of a novel treatment for GAD has significant implications for the millions of people worldwide who suffer from this debilitating condition, offering new hope for improved mental health outcomes. This breakthrough could also pave the way for further research into innovative treatments for other mental health disorders.

"On behalf of the 20 million people in the US and millions more worldwide who are living with GAD, we are incredibly excited for the therapeutic potential that MM120 shows based on its rapid and robust efficacy durably sustained for 12 weeks after a single dose in this study," said Daniel R. Karlin, MD, MA, Chief Medical Officer of MindMed. "Few new treatment options have shown robust activity in GAD with the last new FDA approval occurring in 2007. We are committed to bringing MM120 to people living with GAD and are excited to move into the next phase of our development program."

The study involved a single oral administration of MM120 100 μg, which demonstrated a 7.7-point improvement over placebo at Week 12 (21.9 MM120 vs. 14.2 placebo, p = 0.003, Cohen's d = 0.81). Clinical Global Impressions Severity (CGI-S) scores improved from 4.8 to 2.2 in the 100μg dose group, representing a two-category shift from "markedly ill" to "borderline ill" at Week 12 (p = 0.004). MM120 was generally well-tolerated, with most adverse events rated as mild to moderate, transient, and occurring on the dosing day.

GAD is a common condition associated with significant impairment that adversely affects millions of people worldwide. The condition is often underdiagnosed and undertreated, with a significant unmet medical need for effective treatments. Two new epidemiology studies presented at the APA meeting quantified the burden of GAD in the US.

One study found that screening the general population for anxiety using the GAD 7 screening tool would identify about three-fold more people living with anxiety than are currently diagnosed in the US. The second study compared diagnosed and undiagnosed people with GAD, finding that the condition's relative impact on their lives was more significant among undiagnosed adults than their diagnosed counterparts.

"As a clinician and clinical researcher, I applaud the way this study was designed by MindMed to isolate the effect of MM120 by removing confounding variables like additional medications and psychotherapy," said Reid Robison, MD, Psychiatrist and Chief Clinical Officer at Numinus. "It gives me confidence in the data and the positive results give me hope that this may translate into meaningful benefits for my patients. "The promising Phase 2b results for MM120 mark a significant step forward in the development of novel treatments for GAD, offering new hope to the millions of people affected by this debilitating condition.

Key Takeaways

• MindMed's Phase 2b study of MM120 shows significant efficacy in treating Generalized Anxiety Disorder (GAD).
• MM120 demonstrates 65% clinical response rate and 48% clinical remission rate at 12 weeks.
• Single dose of MM120 shows rapid and durable improvements in anxiety symptoms.
• MM120 is generally well-tolerated with mild to moderate adverse events.
• Study results offer new hope for improved mental health outcomes for millions of people with GAD.