The investigational monoclonal antibody nipocalimab is associated with significant improvement in patients with generalized myasthenia gravis phase 3 results suggest.
The VIVACITY-MG3 trial is the first registrational study of a neonatal fragment crystallizable receptor blocker to show sustained efficacy through 6 months of fixed schedule dosing.
The double-blind, placebo-controlled trial included 196 adults with a broad range of seropositive gMG – who account for approximately 95% of the gMG patient population – and 42 seronegative patients. The primary efficacy endpoint was the Myasthenia Gravis Activities of Daily Living score. Participants treated with nipocalimab demonstrated a statistically significant improvement of 4.70 points from baseline, compared to the 3.25-point improvement in those treated with placebo was significantly greater in the nipocalimab versus placebo arms ,” said Vu.
“It’s a phase 3 trial, it’s positive, which is great, so it'll be another drug on the market, another option for our patients,” she said. However, she cautioned, “their placebo arm did better than most placebos, so I think the delta is not as robust, but it was still statistically significant.
Muscular Atrophy Muscular Atrophies Monoclonal Antibody Cetuximab Rituximab Biologic Therapy Biologics Rare Diseases Receptors Muscle Spasm Iga Immunoglobulin A Muscles Peripheral Edema Adverse Effects Side Effects California Clinical Research Clinical Trials Clinical Studies Pre-Clinical Trial Double-Blind Study Double-Blind Studies Single-Blind Study
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