JOHNSON & JOHNSON
Response was demonstrated as early as Week 4 and continued to increase throughout the 24-week treatment period compared with patients receiving placebo. These data represent the first positive results in SjD for nipocalimab. The study results were featured in a late-breaking presentation (LBA0010) and are among 30 abstracts that the Company is presenting at the
'These data establish proof of concept for nipocalimab in Sjogren's disease and support further clinical development, which is welcome news for the approximately four million people worldwide living with this chronic, debilitating disease,' said Prof.
In addition to achieving the primary endpoint, the nipocalimab 15 mg/kg treatment group demonstrated: Clinically meaningful improvements in secondary endpoints at Week 24 including multiple organ assessments (DALc), physician assessments (PhGAd), and composite tools for clinical trial endpoints (STARe, CRESSf)
Improvement trends in important SjD symptoms including mouth dryness, eye dryness, and vaginal dryness
Safety and tolerability consistent with other nipocalimab clinical studies
Furthermore, lowering levels of total IgG and autoantibodies associated with SjD (e.g. anti-Ro60 and -La/SSB) are highly consistent with the nipocalimab mechanism of action, exhibiting reductions similar to those observed in prior nipocalimab clinical studies.
'A clear need exists for patients living with Sjogren's disease to have advanced therapies that target the underlying cause and systemic nature of this disease, as none have been approved to date,' said
About Sjogren's Disease (SjD)
Sjogren's disease (SjD) is one of the most prevalent autoantibody driven diseases for which no therapies are currently approved that treat the underlying and systemic nature of the disease.3 It is a chronic autoimmune disease that is estimated to impact approximately four million people worldwide and is nine times more common in women than men.1,2 SjD is characterized by autoantibody production, chronic inflammation, and lymphocytic infiltration of exocrine glandular systems. Most patients are affected by mucosal dryness (eyes, mouth, vagina), joint pain and fatigue.3 Extraglandular manifestations are common and may impact multiple organ systems, including joints, lungs, kidneys, and nervous system.5 Patients with SjD have a high risk of developing numerous associated conditions, including up to 20 times higher risk of developing B-cell lymphomas when compared to the general population. SjD increases all-cause mortality risk by approximately 50% more than the general population, and high activity in more than one organ/disease domain increases mortality risk by up to five-fold.3,4 Disease burden can be as high as that of rheumatoid arthritis or systemic lupus erythematosus. It is usually associated with impaired quality of life and functional capacity.
About DAHLIAS
DAHLIAS is a Phase 2 multicenter, randomized, placebo-controlled double-blind study to evaluate the effects of nipocalimab in participants with primary Sjogren's disease. DAHLIAS includes a Phase 2 dose-ranging study for adults with moderately-to-severely active primary SjD who were seropositive for anti-Ro60 and/or anti-Ro52 IgG antibodies. One hundred sixty three adults aged 18-75 were randomized 1:1:1 to receive intravenous nipocalimab at 5 or 15 mg/kg or placebo every 2 weeks through Week 22 and received protocol-permitted background standard of care. Safety assessments were conducted through Week 30.
About Nipocalimab
Nipocalimab is an investigational monoclonal antibody, purposefully designed to bind with high affinity to block FcRn and reduce levels of circulating immunoglobulin G (IgG) antibodies, while preserving immune function without causing broad immunosuppression. This includes autoantibodies and alloantibodies that underlie multiple conditions across three key segments in the autoantibody space including Rare Autoantibody diseases, Maternal Fetal diseases mediated by maternal alloantibodies and Prevalent Rheumatology.
Blockade of IgG binding to FcRn in the placenta is also believed to prevent transplacental transfer of maternal alloantibodies to the fetus.
The
Orphan drug status for wAIHA in
Breakthrough Therapy Designation for HDFN in
Orphan medicinal product designation for HDFN by the
About
At
Cautions Concerning Forward-Looking Statements
This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of nipocalimab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of
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