J&J EMEA Immunology therapeutic area head Mark Graham tells Srivani Venna that based on positive data from the Phase II JASMINE study, the company aims to explore nipocalimab’s potential to specifically target disease-driving pathways in systemic lupus erythematosus (SLE), such as pathogenic immunoglobulin G (IgG) autoantibodies.
This commitment is reflected in the launch of the Phase III GARDENIA study, which will further assess nipocalimab over a 52-week period.
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Mark tells Pharmaceutical Technology that as the Phase III GARDENIA study progresses, J&J will share further results, confident in nipocalimab’s potential not only in SLE but also across other autoimmune conditions, where there is a similar need for innovative treatments.
Srivani Venna (SV): Given nipocalimab’s positive results in the Phase II JASMINE study, what are the key steps J&J will take over the next 6–12 months to advance its development for SLE?
Mark Graham (MG): Despite advances in therapy, there is a continued need to develop additional treatment options for people living with SLE that help directly target disease-driving pathways, including pathogenic immunoglobulin G (IgG) autoantibodies.
We are committed to addressing these unmet needs and following the positive results from our Phase II JASMINE study, we are continuing to evaluate nipocalimab as a potential treatment in adults living with active SLE in the Phase III GARDENIA study.
SV: How does nipocalimab’s mechanism of action translate into tangible benefits for patients with SLE, and what clinical data supports this?
MG: Nipocalimab is designed to target and reduce pathogenic IgG autoantibodies, which are believed to be an underlying driver of disease in SLE. By targeting this driver, nipocalimab has the potential to help address a significant unmet need for people living with SLE.
The Phase II JASMINE results support the potential for nipocalimab to provide disease control over time for a broad population of autoantibody-positive adult patients living with moderate-to-severe SLE, a disease in which many patients experience ongoing disease activity and risk of systemic organ damage.
Importantly, almost 40% of patients receiving nipocalimab 15 mg/kg plus background medication achieved Lupus Low Disease Activity State (LLDAS) at week 52 compared with around 20% of patients receiving placebo plus background medication.LLDAS is a key exploratory endpoint that enables a treat-to-target approach, in which treatment is guided by regular assessment of disease activity and adjusted to achieve remission, or low disease activity if remission is not attainable, to improve long-term outcomes and help prevent organ damage.
In addition, nipocalimab demonstrated a safety profile consistent with previous studies, with no new safety signals identified.
SV: What specific outcomes in the Phase III GARDENIA study will determine nipocalimab’s efficacy and safety in treating SLE, and what changes would indicate clinically meaningful results?
MG: The Phase III GARDENIA study is evaluating whether treatment with nipocalimab can improve disease activity outcomes after 52 weeks of treatment, including SLE Responder Index 4 (SRI-4) composite response and Lupus Low Disease Activity State (LLDAS), in patients with moderate-to-severe SLE. The study is ongoing, and we look forward to sharing the results when they become available.
SV: How could the findings from the nipocalimab programme support its use in other autoimmune conditions, and which diseases are priorities for J&J’s future investigations?
MG: Nipocalimab is currently approved in the European Union as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG), in adults and adolescent patients aged 12 years of age and older who are anti-AChR or anti-MuSK antibody positive.
This demonstrates the clinical relevance of the autoantibody pathway, and targeting of the neonatal Fc receptor (FcRn) in SLE. Nipocalimab is designed to target, bind with high affinity, and block FcRn, reducing circulating IgG antibodies that drive disease. The Phase II JASMINE study is the first proof-of-concept for a FcRn blocker in SLE, strengthening our understanding of the role of FcRn in autoantibody-driven diseases.
Nipocalimab isbeing investigated across three key segments: Rare Autoantibody – ranging from neurologic to haematologic; Maternal Foetal alloimmune diseases of pregnancy and Rheumatologic autoantibody-driven diseases, in multiple potential indications, each with hig
