Positive sibeprenlimab Phase III results in IgAN released by Otsuka

Japan’s Otsuka (TYO: 4578) has announced positive findings from a 12-month interim analysis of sibeprenlimab for the treatment of immunoglobulin A nephropathy (IgAN) in adults from the Phase III VISIONARY study.

The data were presented at the 2025 American Society of Nephrology (ASN) annual Kidney Week meeting in Houston, Texas.

At 12 months, sibeprenlimab showed a reduction in uPCR-24h of 56.6% (95% CI, 50.8% to 61.7%) compared with 5.1% (-6.7% to 15.7%) for placebo, corresponding to a placebo-adjusted reduction in uPCR-24h of 54.3% (95% CI, 46.4% to 60.9%). The safety profile was favorable and consistent with placebo. At the time of the interim analysis cutoff, the incidence of treatment-emergent adverse events in the safety set (n=510) was similar in the sibeprenlimab (74.1%) and placebo (82.1%) groups, the majority of which were mild to moderate in severity. The most common events were upper respiratory tract infections (14.7% for sibeprenlimab vs. 13.9% for placebo) and nasopharyngitis (12.4% for sibeprenlimab versus 10.0% for placebo).