Johnson & Johnson (JNJ), a pharmaceutical company, on Wednesday reported new biomarker analyses data from the Phase 2 DAHLIAS trial evaluating Nipocalimab in treating Sjogren's disease.
Sjogren's disease is a chronic, autoantibody-driven autoimmune disease characterized by mucosal dryness, joint pain, and fatigue. Affecting women nine times more often than men, the disease impacts over four million people worldwide, yet there is no approved therapy that addresses the disorder's underlying cause. Patients often face an impaired quality of life, reduced functional capacity and restricted mobility.
Nipocalimab is an investigational, immunoselective treatment developed to block neonatal Fc receptor (FcRn) and reduce circulating immunoglobulin G (IgG) antibodies that drive autoimmune diseases. The drug was developed for the treatment of rheumatologic, maternal fetal, and rare autoantibody diseases, and has been granted Fast Track and Breakthrough designations by the U.S. FDA for treating Sjogren's disease.
The Phase 2 DAHLIAS trial is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study conducted with 163 patients of Sjogren's disease. The primary endpoint measured improvements at week 24 on the ClinESSDAI scale, which assesses disease activity across 11 organ system domains.
Biomarker analyses suggests that patients with higher levels of autoantibodies and IgG levels showed a more substantial clinical response rate, showing a 62.5% improvement in ClinESSDAI scores compared to the 51.9% seen in the overall patient population.
The company plans to utilize the biomarker data in advancing nipocalimab in the ongoing Phase 3 DAFFODIL trial for the systemic management of Sjogren's disease.
JNJ closed Tuesday at $222.89, down 0.28%. In the pre-market, shares are trading at $223.04 up 0.05%.
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