POS-108 A PHASE 1/2, MULTICENTER TRIAL TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF BION-1301 IN HEALTHY VOLUNTEERS AND ADULTS WITH IgA NEPHROPATHY

Abstract

IgA nephropathy (IgAN) is the most common primary glomerulonephritis globally, with up to 45% of IgAN patients at risk of progressing to ESKD. There are currently no approved treatments specifically for IgA nephropathy. The initiating step in IgAN pathogenesis is the excess production of galactose-deficient IgA1 (Gd-IgA1) resulting in formation of pathogenic immune complexes that cause kidney inflammation and damage. A Proliferation-Inducing Ligand (APRIL), a TNF-superfamily cytokine, is elevated in IgAN patients and correlated with higher levels of Gd-IgA1 and proteinuria, and lower eGFR.