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Johnson & Johnson (J&J) has announced that its monoclonal antibody drug nipocalimab met the primary endpoint of decreasing disease activity at 24 weeks as measured by SLE Responder Index 4 (SRI-4) and continued to demonstrate sustained reduction in disease activity in adults with moderate-to-severe systemic lupus erythematosus (SLE) through 52 weeks in the phase 2 JASMINE study as measured by both SRI-4 and Lupus Low Disease Activity State (LLDAS).
In addition, the study results showed greater response versus placebo plus background medication in participants who tested positive for lupus-associated autoantibodies, which represents the vast majority (~80%) of people living with SLE. These findings will be featured in a late-breaking presentation at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress in London and are among the 38 abstracts the Company is presenting across its Rheumatology portfolio.
Nipocalimab is the first and only neonatal Fc receptor (FcRn) blocker to be studied in systemic lupus erythematosus – designed to target and reduce pathogenic immunoglobulin G (IgG) autoantibodies associated with this disease while preserving immune function. The results demonstrated significant reduction of systemic lupus erythematosus disease activity which continued beyond the 24-week primary endpoint, and were sustained through Week 52 in the nipocalimab 15 mg/kg group.
The ongoing phase 3 study of nipocalimab is currently recruiting people living with systemic lupus erythematosus – a debilitating autoantibody-driven disease which can lead to systemic organ damage.
Nipocalimab is designed to selectively block the neonatal Fc receptor (FcRn), reducing levels of circulating pathogenic immunoglobulin (IgG) autoantibodies and immune complexes associated with inflammation in SLE. By reducing circulating IgG, including autoantibodies, nipocalimab is designed to target the underlying cause of disease while preserving critical immune functions. JASMINE is the first clinical study to demonstrate efficacy of FcRn blockade in SLE and provides clinical, biomarker and pharmacodynamic evidence supporting the continued investigation of nipocalimab as a potential treatment option for this disease.
"The consistent improvements observed across established disease activity measures and reductions in pathogenic immunoglobulin G autoantibodies are encouraging and support the continued investigation of nipocalimab as a targeted treatment approach for people living with systemic lupus erythematosus," said Richard Furie, M.D., chief of the division of rheumatology at Northwell. "These 52-week findings support the potential of nipocalimab to provide disease control over time for a broad population of autoantibody-positive adult patients living with moderate-to-severe systemic lupus erythematosus, a disease in which many patients experience ongoing disease activity and risk of irreversible organ damage."
The phase 2 JASMINE study is the first proof-of-concept for a FcRn-blocker in SLE and demonstrates the potential of nipocalimab to reduce disease activity, with greater responses observed in autoantibody-positive patients. The study met its primary endpoint at Week 24, with a greater proportion of patients receiving nipocalimab 15 mg/kg plus background medication achieving an SRI-4b response compared with placebo plus background medication (53.5% vs 46.7%).
In a predefined autoantibody-positive patient populatione, greater SRI-4 response rates were observed (58.2% vs. 36.1%) and greater achievement of LLDAS (38.9% vs. 18.0%) compared with placebo plus background medication at Week 52.
At Week 52, a key secondary endpoint, 53.6% of patients receiving nipocalimab 15 mg/kg achieved an SRI-4b response, compared with 39.7% for placebo plus background medication. More patients receiving nipocalimab 15 mg/kg also achieved LLDAS, a key exploratory endpoint that enables a treat-to-target approach, compared with placebo plus background medication (37.5% vs. 20.5%) at Week 52. Nipocalimab had a safety profile consistent with previous studies of nipocalimab and no new safety signals were identified. The most common adverse reactions in patients with SLE treated with nipocalimab (=10%) were nasopharyngitis, headache, urinary tract infection and nausea.
"The JASMINE results provide important new insights into the potential of nipocalimab for adults with moderate-to-severe systemic lupus erythematosus as we continue advancing this program," said Leonard L. Dragone, M.D., Ph.D., Disease Area Leader, Autoantibody and Rheumatology, Johnson & Johnson.
"We are especially encouraged by the responses observed in autoantibody-positive study participants. These findings support the potential of nipocalimab as a targeted, immunoselective treatment designed to address underlying drivers of systemic lupus erythematosus."
Nipocalimab received Fast Track Designation in SLE by the US Food and Drug Administration (FDA) earlier this year. The ongoing Phase 3 GARDENIA study is currently recruiting.
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