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Nipocalimab has demonstrated clinical efficacy for the treatment of generalized myasthenia gravis (gMG) and Sjögren's disease (SjD), according to topline results from pivotal phase 2 and 3 trials.¹

The drug, an investigational, high-affinity, fully human, aglycosylated, effectorless, monoclonal antibody designed to selectively block the neonatal Fc receptor (FcRn), has previously proven its efficacy in the treatment of rheumatoid arthritis (RA) and hemolytic disease of the fetus and newborn (HDFN).^2,3 It works by reducing the levels of circulating immunoglobulin G (IgG) antibodies, including autoantibodies and alloantibodies associated with various conditions. Nipocalimab has the potential to lower autoantibody levels while preserving immune function, and it may prevent the transplacental transfer of maternal alloantibodies to the fetus.

Nipocalimab is currently being studied across 3 key segments in the autoantibody space: Rare Autoantibody, including gMG; Maternal Fetal diseases mediated by maternal alloantibodies, such as HDFN; and Prevalent Rheumatology, including RA, SjD, and systemic lupus erythematosus (SLE).

The VIVACITY Trial

Approximately 700,000 people are diagnosed with myasthenia gravis (MG) globally, 85% of which are subsequently diagnosed with the more extensive form of the disease, gMG. The condition disrupts neuromuscular signaling and impacts muscle contraction. Common symptoms include double vision, drooping eyelids, weakness in the limbs, and difficulties involving speech, breathing, swallowing, and chewing.

The randomized, double-blind, placebo-controlled phase 3 VIVACITY study recruited patients with moderate to severe gMG, a chronic and debilitating autoantibody-driven neuromuscular disease defined by fluctuating muscle weakness. Elligible patients experienced insufficient response to standard-of-care treatment

The primary endpoint was met, with patients achieving a statistically significant reduction in the Myasthenia Gravis – Activities of Daily Living (MG-ADL) score from baseline over 22 to 24 weeks when compared with placebo.

The DAHLIAS Trial

SjD, another prevalent and debilitating autoantibody disease without approved advanced treatments, effects approximately 350,000 people in the US and is 9 times more common in women than men. The condition is characterized by chronic inflammation, lympocytic infiltration of the exocrine glandular systems, and autoantibody production.

Patients often experience symptoms including joint pain, fatigue, mucosal dryness, and the disease can affect the lungs, kidneys, and nervous system. In addition to reduced functional capacity and quality of life, these patients are at an up to 20 times higher risk of developing B-cell lymphomas when compared with the general population.

In the dose-ranging phase 2 DAHLIAS trial, patients with SjD with moderate to severe disease activity despite standard of care had a statistically significant reduction in the Clinical EULAR Sjögren's Syndrome Disease Activity Index (ClinESSDAI) score from baseline to week 24 compared with placebo. The ClinESSDAI evaluates organ disease activity across 11 organ system domains.

Nipocalimab was well-tolerated in both studies, and Johnson & Johnson plans to share the comprehensive results at upcoming scientific medical meetings while seeking regulatory approval for gMG and advancing clinical development in SjD.

"We look forward to sharing the comprehensive results of these important studies at upcoming scientific medical meetings," Katie Abouzahr, M.D., Vice President, Autoantibody and Maternal Fetal Immunology Disease Area Leader, Johnson & Johnson, said in a statement.¹ "Johnson & Johnson is committed to addressing the immense unmet patient need in these chronic and debilitating autoantibody-driven diseases.”

References

1. ^{Janssen Pharmaceutical Companies of Johnson & Johnson. Janssen reports positive topline phase 2 results for Nipocalimab in pregnant individuals at high risk for severe hemolytic disease of the fetus and newborn (HDFN). PR Newswire: press release distribution, targeting, monitoring and marketing. February 6, 2023. Accessed February 5, 2024. https://www.prnewswire.com/news-releases/janssen-reports-positive-topline-phase-2-results-for-nipocalimab-in-pregnant-individuals-at-high-risk-for-severe-hemolytic-disease-of-the-fetus-and-newborn-hdfn-301738963.html.}
2. ^{Pine L. Peter C Taylor, Phd: NIPOCALIMAB shows promise in rheumatoid arthritis treatment. HCP Live. December 8, 2023. Accessed February 5, 2024. https://www.hcplive.com/view/peter-c-taylor-phd-nipocalimab-shows-promise-in-rheumatoid-arthritis-treatment.}
3. ^{Grossi G. NIPOCALIMAB benefits mechanism of HDFN in phase 2 trial. HCP Live. June 26, 2023. Accessed February 5, 2024. https://www.hcplive.com/view/nipocalimab-benefits-mechanism-hdfn-phase-2-trial.}