Healthcare products company Johnson & Johnson (J&J) (NYSE:JNJ) on Thursday announced the publication of data in mAbs, a peer-reviewed, open access journal, detailing the unique molecular properties of nipocalimab, an investigational neonatal Fc receptor (FcRn) blocker.
The data demonstrate nipocalimab's high-affinity binding to FcRn, which leads to a reduction in IgG levels, including pathogenic autoantibodies, by over 75%.
Nipocalimab's pH-independent binding supports its potential use in treating IgG-driven alloantibody and autoantibody diseases, with no detectable effects on other immune functions.
The mechanism of action of nipocalimab was assessed through in vitro and in vivo studies, and attributes noted in the publication are consistent with clinical Phase 1, 2 and 3 studies.
The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted several designations to nipocalimab, including Fast Track and Orphan Drug status for various conditions, such as haemolytic disease of the foetus and newborn (HDFN), warm autoimmune haemolytic anaemia (wAIHA) and foetal neonatal alloimmune thrombocytopenia (FNAIT).
Nipocalimab's clinical significance remains to be determined as further studies continue.
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Johnson & Johnson reports nipocalimab Phase 3 study results published in The Lancet Neurology