RemeGen reported a prespecified interim analysis from a Phase 3 program evaluating telitacicept in adults with biopsy-proven IgA nephropathy and persistent proteinuria. In the 318-patient study, weekly subcutaneous telitacicept (240 mg) produced a substantially larger reduction in urinary protein-to-creatinine ratio at 39 weeks than placebo. At week 39, the 24-hour protein-to-creatinine ratio fell 58.9% with telitacicept versus 8.8% with placebo, corresponding to a relative difference of −55.0% (P<0.001). Estimated glomerular filtration rate showed minimal between-group separation, with change of −1.0% on telitacicept versus −7.7% on placebo. Safety signals included higher adverse event rates on telitacicept (89.3% vs 78.6%), while serious adverse events were numerically lower (2.5% vs 8.2%). The company said there were no unexpected safety findings. The trial targets BAFF and APRIL biology via a fusion protein that neutralizes both, aligning with the known cytokine axis driving disease activity in IgA nephropathy. Further regulatory and clinical decision-making will likely hinge on the durability of proteinuria reduction and expanded safety review.
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