MindMed Presents Phase 2b Study of MM120 for Generalized Anxiety Disorder (GAD) at American Psychiatric Association (APA) Annual Meeting in New York - Seite 2

In today’s presentation of the Phase 2b study with MM120, investigators presented results from the assessment of several additional secondary endpoints that were pre-specified. One such endpoint was the change from baseline compared to placebo in Montgomery-Åsberg Depression Rating Scale (MADRS) scores, which measures the severity of depression symptoms. Major Depressive Disorder (MDD) and depressive symptoms are common co-morbidities in people with GAD. MADRS score improvements in the 100 µg arm of the study were clinically and statistically significant compared to the placebo group, with a difference of 5.7 points (p≤0.05) at week 4 and a difference of 6.4 points (p≤0.05) at week 12.

In MMED008, MM120 was generally well-tolerated, with most adverse events rated as mild to moderate, transient, and occurring on the dosing day (day 1) and being consistent with the expected acute effects of the study drug. The most common adverse events, with at least 10% incidence on dosing day in the 100µg dose group, included illusion, nausea, headache, hallucination, euphoric mood, anxiety, mydriasis, hyperhidrosis, paresthesia, fatigue, blood pressure increase, abnormal thinking, and altered state of consciousness.

Prior to treatment with MM120, study participants were clinically tapered and then washed out from any anxiolytic or antidepressant treatments and were not provided study-related psychotherapy for the duration of their participation in the study.

“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 (TSX:NUMI) who has served as adjunct faculty at the University of Utah for the last 12 years and was a co-author in the MM120 study. “It gives me confidence in the data and the positive results give me hope that this may translate into meaningful benefits for my patients.”

New Data on the Burden of GAD

Two additional studies with new epidemiological data were also presented today by MindMed at the APA meeting. One study strongly supports screening the general population for anxiety as recommended by the US Preventive Services Task Force (USPSTF), indicating that using the clinically validated GAD-7 screening tool would identify about three-fold more people living with anxiety than are currently diagnosed in the US.