Mind Medicine (MindMed) Inc.
(NASDAQ: MNMD) (NEO: MMED) (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, announced today that it has completed enrollment and dosing in Study MMED008, the Company’s Phase 2b study evaluating MM-120 (lysergide D-tartrate) for the treatment of GAD.
“Completion of enrollment of this study is a significant milestone for MindMed and moves us one step closer to our goal of transforming the treatment of GAD for the millions suffering from the disorder,” said Robert Barrow, Chief Executive Officer and Director of MindMed. “Thanks in large part to the enthusiasm we have seen regarding MM-120 among investigators and patients, as well as the strong execution of our team, we were able to enroll almost 200 participants in this trial in just over a year. We anticipate sharing topline results during the fourth quarter of this year.”
Study MMED008 is a multi-center, parallel, randomized, double-blind, placebo-controlled, dose-optimization study. The trial has enrolled 198 participants who were randomized to receive a single administration of 25 µg, 50 µg, 100 µg or 200 µg of MM-120, or placebo. The primary objective of the study is to determine the dose-response relationship of four doses of MM-120 versus placebo as measured by the change in Hamilton Anxiety Rating Scale (HAM-A) from baseline to week 4. Key secondary objectives, measured up to 12 weeks after the single administration, include assessments of anxiety symptoms, safety and tolerability, as well as other measures of efficacy and quality of life. More information about the trial is available on our website (mindmed.co), the trial’s website (anxietyresearchstudy.com) or on clinicaltrials.gov (identifier NCT05407064).