Johnson & Johnson's Potential Best-in-Class Antibody Nipocalimab Meets Primary Endpoint in Phase 3 Trial for Generalized Myasthenia Gravis and Shows Efficacy in Sjögren’s Disease

Feb 06, 2024 07:30 CST Updated 07:30

Johnson & Johnson

Medical Device R&D and Manufacturer

▎Edited by the WuXi AppTec content team

Today, Johnson & Johnson announced,Nipocalimab, an investigational antibody, achieved positive topline results in the pivotal Phase 3 clinical trial, VIVACITY, for the treatment of adult patients with generalized myasthenia gravis (gMG).In addition, nipocalimab also demonstrated efficacy in the Phase 2 clinical trial DAHLIAS for the treatment of adult patients with Sjögren's syndrome (SjD).The press release pointed out,Nipocalimab has demonstrated clinical efficacy in four autoimmune antibody-mediated diseases over the past year., including hemolytic disease of the fetus and newborn (HDFN), rheumatoid arthritis, gMG, and SjD.

In the Phase 3 clinical trial VIVACITY for the treatment of gMG,Nipocalimab met the primary endpoint, with a significant reduction in the disease indicator MG-ADL score at weeks 22-24 compared to placebo.gMG is a chronic, lifelong, rare, and extremely debilitating autoantibody-mediated neuromuscular disorder characterized by muscle weakness.

Nipocalimab is a potential "best-in-class" antibody therapy targeting the neonatal Fc receptor (FcRn).It binds to FcRn, allowing autoantibodies taken up by monocytes and endothelial cells to be degraded within the cells rather than being released back into the bloodstream. Existing studies have shown,It can reduce the level of IgG, including pathogenic autoantibodies in the blood circulation, by more than 75%.This antibody therapy has the potential to treat various autoimmune antibody-mediated immune diseases.

▲Introduction to Nipocalimab (Image Source:Johnson & Johnson Official Website）

In the phase 2 clinical trial DAHLIAS for the treatment of SjD, nipocalimab also met the primary endpoint, with a significant reduction in clinESSDAI score at week 24 compared to placebo. The press release noted,These data represent the first positive clinical trial results for anti-FcRn antibodies in this autoimmune disease.Participants in both studies tolerated nipocalimab well.

Looking ahead, Johnson & Johnson plans to present the full results of the VIVACITY study at upcoming medical conferences and will discuss with global regulatory authorities on how to bring nipocalimab to gMG patients. The results of the DAHLIAS study support further clinical development of nipocalimab in SjD, with the full results to be presented at this year’s medical conferences.

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References:

[1] Johnson & Johnson reports positive topline results for nipocalimab from a Phase 3 pivotal study in generalized myasthenia gravis (gMG) and a Phase 2 study in Sjögren's Disease (SjD). Retrieved February 5, 2024, from https://www.prnewswire.com/news-releases/johnson--johnson-reports-positive-topline-results-for-nipocalimab-from-a-phase-3-pivotal-study-in-generalized-myasthenia-gravis-gmg-and-a-phase-2-study-in-sjogrens-disease-sjd-302053304.html

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