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

Based on the significant unmet medical need in the treatment of GAD – especially in patients who do not respond to or tolerate currently available medications – along with the initial clinical data from Phase 2b and other research conducted by MindMed, the U.S. Food & Drug Administration (FDA) has designated MM120 for GAD as a breakthrough therapy. The Company plans to hold an End-of-Phase 2 meeting with the FDA in the first half of 2024 and initiate a Phase 3 clinical program in the second half of 2024.

“The FDA’s decision to designate MM120 as a breakthrough therapy for GAD and the durability data from our Phase 2b study provide further validation of the important potential role this treatment can play in addressing the huge unmet need among individuals living with GAD,” said Robert Barrow, Chief Executive Officer and Director of MindMed. “We are committed to bringing MM120 to people living with GAD and delivering on the potential of our pipeline to treat serious brain health disorders.”

In the Phase 2b study, known as MMED008, MM120 was generally well-tolerated with most adverse events rated as mild to moderate, transient and occurring on dosing day, and being consistent with expected acute effects of the study drug. The most common adverse events (at least 10% incidence in the high dose groups) on dosing day included illusion, hallucinations, euphoric mood, anxiety, abnormal thinking, headache, paresthesia, dizziness, tremor, nausea, vomiting, feeling abnormal, mydriasis and hyperhidrosis.

Prior to treatment with MM120, study participants were clinically tapered and then washed out from any anxiolytic or antidepressant treatments and did not receive any form of 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 an investigator 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.”