The associate professor of neurology and neurologist at Duke University discussed the positive results of nipocalimab, a monoclonal antibody, in patients with myasthenia gravis.
"The drug was well-tolerated and safe. There were no adverse events that resulted in discontinuation of the treatment, as well as no serious adverse events. There were no dose-dependent increases in adverse events."
The phase 2 double-blind, placebo-controlled, Vivacity-MG study (NCT03772587), assessing the investigational therapeutic nipocalimab (Janssen Pharmaceuticals), revealed that the treatment is well-tolerated, safe, and efficacious in patients with generalized myasthenia gravis (gMG). Nipocalimab is a fully human, aglycosylated, effectorless immunoglobulin G1 (IgG) anti-FcRN antibody that functions to reduce the levels of other IgG antibodies in the blood, including the autoantibodies that cause gMG.
Presented at the 2021 American Academy of Neurology (AAN) Annual Meeting, April 17-22, the data showed that treatment with nipocalimab resulted in a robust and significantly greater mean improvement from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) scores across all continuous dosing arms compared to placebo at the end of the 8-week treatment period.
Led by Jeffrey Guptill, MD, MS, MHS, associate professor of neurology and neurologist, Duke University, the results open the door to future studies involving nipocalimab. As part of NeurologyLive’s ongoing coverage of AAN 2021, Guptill sat down to discuss the results of the study, including some of the top-level findings and their significance to the clinical community.
For more coverage of AAN 2021, click here.