The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has announced the results of a Phase II trial for nipocalimab, a potential best-in-class anti-neonatal Fc (FcRn) biologic, in patients with moderate-to-severe active rheumatoid arthritis (RA) who have anti-citrullinated protein antibodies (ACPAs) or rheumatoid factor (RF) and are unresponsive to anti-tumor necrosis factor (anti-TNF) therapy.
Phase II Trial Results
After 12 weeks of treatment, patients receiving nipocalimab experienced a significant improvement in the DAS28-CRP score, decreasing from -0.58 to -1.03 compared to the placebo group. The remission rate, as measured by DAS28-CRP, increased to 21.2% from 10.0% in the control group. Additionally, a higher proportion of patients treated with nipocalimab achieved an ACR50 response, with 15.2% versus 5.0% in the placebo arm.
Implications of the Data
Janssen views these results as evidence of nipocalimab’s FcRn-blocking mechanism, which reduces the levels of circulating immunoglobin G (IgG) antibodies, including ACPAs. This confirms the key role of ACPAs in RA and the potential of nipocalimab as a targeted therapy.
Next Steps for Nipocalimab
Building on the positive outcomes, Janssen has advanced nipocalimab to a Phase II combination study with an anti-TNFα treatment for RA. The biologic drug is also under development for other rheumatic diseases, maternal-fetal immune diseases, and rare autoantibody conditions, indicating its broad potential in treating various immune-mediated disorders.-Fineline Info & Tech
