Telitacicept, developed by RemeGen, showed a significant reduction in proteinuria in a prespecified interim analysis of a phase 3 trial in high-risk IgA nephropathy patients. In NEJM-published results (TELIGAN, NCT05799287), 39 weeks of once-weekly subcutaneous telitacicept (240 mg) reduced the 24-hour urinary protein-to-creatinine ratio by −58.9% versus −8.8% with placebo, with a relative difference favoring active treatment of −55.0% (P<0.001). Estimated glomerular filtration rate changes were −1.0% with telitacicept versus −7.7% with placebo; adverse events were more common with telitacicept, while serious adverse events were lower in the active arm. The data directly informs ongoing development and potential labeling discussions for an IL-BAFF/APRIL-targeting strategy in a competitive IgA nephropathy market where proteinuria reduction is a key clinical and regulatory lever.
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