Carlo Antozzi, MD, discusses results from the phase 3 Vivacity-MG3 study of nipocalimab in antibody positive adults with generalized myasthenia gravis (MG).
MG is a chronic autoimmune neuromuscular disease characterized by weakness of the skeletal muscles. Common symptoms include weakness of the muscles that control the eye and eyelid, facial expressions, chewing, talking, and swallowing. Weakness tends to increase during periods of activity and improve after periods of rest. The condition results from a defect in the transmission of nerve impulses to muscles. This is due to the presence of antibodies against acetylcholine. The exact reason this occurs is not known.
The Vivacity-MG3 clinical trial (NCT04951622) was a phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of nipocalimab in antibody positive adults with generalized MG. Nipocalimab is an investigational FcRn blocker designed to reduce levels of circulation immunoglobulin G (IgG).
In total, 199 patients, 153 of whom were antibody positive, enrolled in the trial. The primary endpoint, of demonstrating statistically significant and clinically meaningful improvement over 24 weeks in the MG Activities of Daily Living (MG-ADL) score, was met. Additionally, nipocalimab demonstrated a 75% reduction in median-pre-dose total IgG from baseline, as well as reduction in levels of antibodies such as AChR and MuSK. The safety profile of nipocalimab was also tolerable with no concerning adverse events compared to placebo.
A Biologics License Application has been submitted to the U.S. Food and Drug Administration as well as a Marketing Authorization Application to the European Medicines Agency for approval of this treatment.
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To learn more about myasthenia gravis and other rare autoimmune conditions, visit https://checkrare.com/diseases/autoimmune-and-auto-inflammatory-disorders/