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Biogen Presents Positive Results from Phase 2 IGNAZ Study of Felzartamab in IgA Nephropathy at American Society of Nephrology (ASN) Kidney Week 2024
BiogenBiogen(US:BIIB) GlobeNewswire News Roomยท2024-10-27 00:15

Core Insights - The Phase 2 IGNAZ study results confirm the efficacy of felzartamab in treating IgA nephropathy, showing significant reductions in proteinuria and stabilization of kidney function over 18 months post-treatment [1][2][3] Company Overview - Biogen Inc. is a leading biotechnology company focused on innovative science to develop new medicines, with a commitment to transforming patients' lives and creating shareholder value [4] Product Development - Felzartamab is an investigational anti-CD38 monoclonal antibody, potentially the first-in-class treatment for various immune-mediated diseases, currently in planning for Phase 3 development [1][3] - The drug has shown a mean reduction of approximately 50% in urinary protein:creatinine ratio (UPCR) through 24 months, indicating its potential to preserve kidney function [2][3] Clinical Study Details - The IGNAZ study involved 54 patients with IgA nephropathy at high risk of progressive kidney dysfunction, demonstrating a nine-dose regimen over six months [2] - Results indicated that patients maintained significant reductions in proteinuria levels and stabilization of kidney function, as measured by estimated glomerular filtration rate (eGFR) [2][3] Safety and Tolerability - Felzartamab was generally well tolerated, with a safety profile consistent with previous studies, and it resulted in selective and durable reductions in IgA antibody levels [3][4]