MindMed Advances in Anxiety Treatment with Successful Phase 2b Study Enrollment

LOS ANGELES — In a significant development in the biopharmaceutical sector, MindMed, a clinical-stage company listed on NASDAQ and NEO has successfully wrapped up the enrollment and dosing phase of a critical study, MMED008. This Phase 2b study is centered on evaluating the efficacy of MM-120 (lysergide D-tartrate) in treating individuals with Generalized Anxiety Disorder (GAD), a prevalent mental health condition characterized by excessive, long-lasting anxiety and worry about nonspecific life events, situations, and objects.

The trial, a comprehensive multi-center initiative, adopted a parallel, randomized, double-blind, placebo-controlled dose-optimization approach. A total of 198 participants were enrolled, with each being randomly assigned to receive a single dosage of MM-120 at varying levels – 25 µg, 50 µg, 100 µg, or 200 µg – or a placebo. The primary focus of this study is to establish a dose-response correlation among the four MM-120 doses in comparison to the placebo. This evaluation will hinge on the changes noted in the Hamilton Anxiety Rating Scale (HAM-A) scores from the baseline to the fourth week.

The HAM-A, a widely recognized tool in psychological circles, is employed to gauge the severity of anxiety symptoms in individuals. It encompasses a series of questions that scrutinize both psychological and physical symptoms of anxiety, including but not limited to nervousness, tension, restlessness, and sleep disturbances.

Beyond the primary goal, the study is slated to scrutinize key secondary objectives over a 12-week period following the initial administration. These objectives include a thorough assessment of anxiety symptoms, ensuring the safety and tolerability of MM-120, and analyzing various other indicators that might point to efficacy and improvements in the quality of life of the participants.

MindMed’s CEO and Director, Robert Barrow, highlighted the milestone as a significant stride towards revolutionizing the treatment landscape for GAD. He noted that the swift enrollment pace, which saw nearly 200 participants joining in just over a year, underscored the enthusiasm from both investigators and patients. Barrow also lauded the efforts of the dedicated team at MindMed and expressed eagerness to share the top-line results, expected to be released in the fourth quarter of this year.

As the biopharmaceutical firm advances in its mission to pioneer innovative treatments for brain health disorders, industry stakeholders and patients alike await further updates on this promising study, with hopes that it might herald a new era in the management of Generalized Anxiety Disorder.