Nipocalimab Shows Promise in Phase 3 gMG and Phase 2 SjD Studies

Nipocalimab, an experimental drug, has shown promising results in treating generalized myasthenia gravis (gMG), a serious autoimmune disorder that has no effective long-term treatments. The drug has also demonstrated efficacy in treating Sjögren's disease (SjD), another prevalent autoimmune condition that lacks advanced treatment options.

In the pivotal Phase 3 VIVACITY trial, nipocalimab significantly reduced the MG-ADL score, a measure of muscle weakness in gMG patients, compared to placebo. This chronic neuromuscular disease is characterized by fluctuating muscle weakness and affects approximately 700,000 people worldwide.

Similarly, in the Phase 2 DAHLIAS study, the drug met its primary endpoint by significantly reducing the clinESSDAI score, which assesses disease activity in SjD patients, compared to placebo. SjD is a chronic autoimmune disease that predominantly affects women and is associated with a higher risk of developing B-cell lymphomas.

Both trials indicated that nipocalimab was well-tolerated by participants. Johnson & Johnson, the company developing the drug, plans to present the full results at upcoming scientific medical congresses and engage with regulatory authorities to make the drug available to patients.

Nipocalimab works by selectively blocking FcRn, a protein that plays a crucial role in the recycling of immunoglobulin G (IgG) antibodies, including those that cause autoimmune diseases. By reducing the levels of these antibodies, the drug aims to control the symptoms of autoimmune disorders.

The drug has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for several indications, including HDFN and gMG, and orphan drug status for conditions like wAIHA and CIDP. However, it is not yet approved and is still under development.

Johnson & Johnson is committed to addressing the significant unmet needs of patients with chronic and debilitating autoimmune diseases. The company is the only one developing an anti-FcRn treatment for key segments of autoimmune diseases, including rare autoantibodies, maternal-fetal immunology, and prevalent rheumatology.

The positive results from the trials of nipocalimab in gMG and SjD are a step forward in the quest for effective treatments for these challenging conditions. The company looks forward to sharing comprehensive results and continuing its efforts to bring innovative solutions to patients suffering from autoimmune diseases.