Otsuka's sibeprenlimab shows positive phase 3 results for IgA nephropathy

Otsuka Pharmaceutical, a subsidiary of Otsuka Holdings, revealed that its novel APRIL antibody, sibeprenlimab, significantly reduced proteinuria in IgA nephropathy patients during the Phase 3 VISIONARY trial. The interim analysis, presented at the American Society of Nephrology (ASN) annual meeting and published in The New England Journal of Medicine, showed a 54.3% reduction in the urinary protein-to-creatinine ratio (uPCR) from baseline compared to placebo at 12 months.

The safety profile of sibeprenlimab was comparable to placebo, with adverse event rates of 74.1% for sibeprenlimab and 82.1% for placebo-treated subjects, indicating good tolerability. The most common adverse events were mild to moderate upper respiratory tract infections and nasopharyngitis.

Sibeprenlimab, a pre-filled syringe for subcutaneous self-administration every four weeks, has received Priority Review designation from the U.S. FDA, with a PDUFA date set for November 28, 2025. The ongoing VISIONARY trial, assessing kidney function changes over 24 months, is expected to conclude in 2026.