Otsuka sibeprenlimab Phase III trial shows 51% reduction in proteinuria

Japan’s Otsuka (TYO: 4578) today presented positive results from a pre-specified interim analysis of the Phase III VISIONARY study (NCT05248646) evaluating sibeprenlimab, for the treatment of immunoglobulin A nephropathy (IgAN) in adults.

The study showed that patients treated with sibeprenlimab achieved a 51.2% (P<0.0001) reduction in proteinuria from baseline (as measured by 24-hour uPCR [urine protein-to-creatinine ratio]) at nine months of treatment when compared  to placebo. The study, the largest Phase III IgAN trial conducted to date, also showed that 76.3% of patients treated with sibeprenlimab experienced treatment emergent adverse events  (TEAEs) versus 84.5% in the placebo group.

Patients who experienced a serious TEAE were 3.9% treated with sibeprenlimab compared to 5.4% treated with placebo. The data were presented during a late-breaking clinical trials session at the European Renal Association (ERA) Congress in Vienna, Austria.