Johnson & Johnson (J&J, NYSE: JNJ), a leading US-based healthcare company, has announced positive results from the Phase III trial for nipocalimab, a potential first-in-class anti-FcRn (neonatal Fc receptor) antibody, for the treatment of generalized myasthenia gravis (gMG). The company has achieved its primary endpoint and is preparing for regulatory submissions in major markets later this year.
In the double-blind, placebo-controlled Vivacity-MG3 study, 199 patients were treated with either nipocalimab plus the standard of care (SOC) or a placebo plus SOC. The primary endpoint, which measured the improvement in MG-ADL score from baseline over 24 weeks, showed that the nipocalimab regimen resulted in a 4.70-point improvement on the MG-ADL. This was a significant advancement compared to the 3.25-point improvement from the placebo plus SOC.
Myasthenia gravis is an autoantibody disease that disrupts neuromuscular signaling, thereby impairing muscle contraction and affecting an estimated 700,000 individuals globally. While the disease typically begins with eye muscle weakness, it generalizes to skeletal muscles in over 53% of patients, leading to limb weakness and difficulties in chewing, swallowing, speaking, and breathing.
The company’s press release highlighted that a 1- to 2-point change on the MG-ADL can significantly affect a patient’s quality of life, such as the difference between normal eating and frequent choking or shortness of breath at rest and reliance on a ventilator. Nipocalimab not only met the primary endpoint but also achieved secondary endpoints, with adverse events leading to discontinuation being comparable to the placebo group. Comprehensive data will be presented at the European Academy of Neurology (EAN) 2024 Congress.
Nipocalimab is also in development for other rare disease indications, including hemolytic disease of the fetus and newborn (HDFN), warm autoimmune hemolytic anemia (wAIHA), and fetal neonatal alloimmune thrombocytopenia (FNAIT).- Flcube.com
