Biogen Inc. (NASDAQ: BIIB), a prominent biopharmaceutical company based in the U.S., has announced comprehensive results from the Phase II IGNAZ study for felzartamab in the treatment of IgA nephropathy. The findings were showcased at Kidney Week 2024, the annual meeting of the American Society of Nephrology. The study demonstrated significant reductions in proteinuria, stabilization of kidney function, and a sustained treatment effect for over 18 months following the last dose of felzartamab.
Felzartamab is an investigational human monoclonal antibody (mAb) that targets CD38 and is being developed to address advanced antibody mediated rejection (AMR) in kidney transplant patients without T-cell mediated rejection. Initially developed by MorphoSys AG, the rights for felzartamab in China, including Macau, Hong Kong, and Taiwan, were licensed to I-Mab in November 2017. Human Immunology Biosciences (HI-Bio) secured the exclusive rights to develop and commercialize felzartamab for all indications globally, excluding China, in June 2022. Biogen’s acquisition of HI-Bio in July 2024 granted it exclusive rights to the drug, excluding China.
Further analysis indicated that felzartamab administration led to selective and durable reductions in IgA antibody levels, with IgG and IgM levels returning to baseline three months after treatment cessation. This selective reduction may allow for the maintenance of significant immune functions crucial for protecting against infections. The administration of felzartamab was generally well tolerated, and its safety profile was consistent with previous studies.- Flcube.com
