Otsuka said two-year Phase 3 data from its VISIONARY study showed VOYXACT, or sibeprenlimab, stabilized kidney function decline to a near-physiologic rate in adults with IgA nephropathy at risk for progression. The company said the results suggest the APRIL inhibitor may fundamentally alter disease progression by preserving kidney function over time.[
According to Otsuka, the findings are based on annualized estimated glomerular filtration rate slope and mean change from baseline over 24 months. The company said the data build on earlier VISIONARY results that showed reductions in proteinuria and support the view that VOYXACT can slow the loss of kidney function more effectively than placebo. Otsuka also said the treatment was well tolerated and had a safety profile consistent with prior interim results.
IgA nephropathy is a chronic kidney disease in which the immune system contributes to progressive damage, and treatment aims to reduce proteinuria and preserve kidney function. Otsuka said the new results align with KDIGO guidance calling for kidney function decline to be reduced to near physiologic levels, or less than 1 mL/min/1.73 m² per year.
The company said VOYXACT is the only APRIL inhibitor to demonstrate statistically significant eGFR stabilization with evidence of improvement versus placebo over two years. Otsuka added that the results reinforce VOYXACT’s potential to provide long-term kidney protection and improve clinical outcomes in IgAN.
Earlier VISIONARY interim data had already shown preservation of kidney function at 12 months, and the study continues to evaluate long-term safety and efficacy over a 24-month period. Future data are expected from an open-label extension study.
Otsuka said the findings will help advance its development program in IgA nephropathy and support its broader effort to address progressive kidney disease with targeted therapy.
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