MindMed Receives FDA Breakthrough Therapy Designation and Announces Positive 12-Week Durability Data From Phase 2B Study of MM120 for Generalized Anxiety Disorder - Seite 3

The primary data analyses from MMED008 have been accepted for presentation at the American Psychiatric Association’s annual meeting, which will be held in New York on May 4-8, 2024. The study is also being submitted for publication in a leading medical journal.

Conference Call and Webcast

MindMed management will host a webcast at 8:00 am ET today to discuss the Phase 2b results of MM120 in GAD. The webcast and slides will be accessible live under “News & Events” on the Investors page of the Company’s website at https://ir.mindmed.co/ or by clicking here. A replay of the event will be available on MindMed’s website. The webcast will be archived on the Company’s website for at least 30 days after the conference call.

About Generalized Anxiety Disorder (GAD)

GAD is a common condition associated with significant impairment that adversely affects millions of people. GAD results in fear, persistent anxiety and a constant feeling of being overwhelmed. It is characterized by excessive, persistent, and unrealistic worry about everyday things. Approximately 10% of U.S. adults, representing around 20 million people, currently suffer from GAD, an underdiagnosed and underserved indication that is associated with significant impairment, less accomplishment at work and reduced labor force participation. Despite the significant personal and societal burden of GAD, there has been little innovation in the treatment of GAD in the past several decades, with the last new drug approval occurring in 2004.

About MMED008

MMED008 was a multi-center, parallel, randomized, double-blind, placebo-controlled, dose-optimization study. The trial enrolled 198 participants who were randomized to receive a single administration of MM120 at a dose of 25, 50, 100 or 200 µg or placebo. The full analysis set (FAS) for the trial included 194 subjects, those that had at least one valid post-baseline Hamilton Anxiety rating scale (HAM-A) score. Subjects enrolled in the trial presented with severe GAD symptoms (average baseline HAM-A scores of approximately 30). The study's main objective was to determine the dose-response relationship of four doses of MM120 versus placebo as measured by the change in HAM-A from Baseline to Week 4. The key secondary objective of the study was to determine the dose-response relationship of four doses of MM120 versus placebo as measured by the change in HAM-A from Baseline to Week 8. Secondary objectives, measured up to 12 weeks after the single administration, include assessments of anxiety symptoms, safety and tolerability, and other measures of efficacy and quality of life. More information about the trial is available on the MindMed website (mindmed.co) or on clinicaltrials.gov (NCT05407064).