Johnson & Johnson Announces Successful Phase III Trial for Autoimmune Treatment

Johnson & Johnson has announced positive outcomes from two separate clinical trials for its monoclonal antibody, Nipocalimab, which is being investigated for its efficacy in treating neuromuscular myasthenia gravis (gMG) and Sjögren’s syndrome (SjD), an autoimmune condition.
In the Phase III clinical trial, named "vivacity," Nipocalimab met its primary endpoint by demonstrating a significant reduction in the myasthenia gravis-activities of daily living (MG-ADL) score when compared to a placebo over a period ranging from 22 to 24 weeks. This trial specifically targeted gMG, a neuromuscular condition that can severely impact a patient's quality of life.
Additionally, in a Phase II trial for Sjögren’s syndrome, labeled "dahlias," Nipocalimab showed a statistically significant decrease in the clinESSDAI score at the 24-week mark when compared to a placebo. Johnson & Johnson highlighted that the drug was well-tolerated by participants in both trials, although the detailed data from these studies were not immediately disclosed.
Kaite Abouzahr, a vice president at Johnson & Johnson and the leader in autoantibody and maternal-fetal immunology diseases, indicated that the company plans to present the complete findings at forthcoming scientific and medical conferences. The drug became part of Johnson & Johnson's portfolio following the acquisition of Momenta Therapeutics for $6.5 billion in 2020.
Abouzahr emphasized Johnson & Johnson's dedication to addressing the significant patient needs in chronic and debilitating autoantibody-driven diseases. The company is unique in developing an anti-FcRn treatment across three critical areas of autoantibody disease: rare autoantibody with gMG, maternal-fetal immunology with hemolytic disease of the fetus and newborn (HDFN), and prevalent rheumatology with the recent SjD results, which complement their existing data in rheumatoid arthritis.
In November 2023, Johnson & Johnson had already released data from a Phase II trial for rheumatoid arthritis, indicating that Nipocalimab led to substantial improvements in efficacy endpoints at week 12. Furthermore, in June 2023, a Phase II study of the drug in pregnant women at high risk for severe hemolytic disease in their fetuses and newborns yielded encouraging results, with a 92% live birth rate among treated pregnancies, and 54% of these patients reaching or exceeding 32 weeks of gestation without the need for intrauterine transfusions.

The announcement of these clinical trial results underscores Johnson & Johnson's ongoing efforts to innovate and provide new treatment options for patients suffering from a range of autoimmune and neuromuscular disorders. The company's commitment to advancing therapies for these conditions reflects its broader mission to improve patient outcomes and address unmet medical needs. As the data from these trials become available, it will provide a more comprehensive understanding of Nipocalimab's potential role in the treatment of these diseases.