Otsuka Pharmaceutical’s Phase 3 VISIONARY clinical trial of sibeprenlimab for the treatment of immunoglobulin A nephropathy (IgA nephropathy) in adults has met its primary endpoint.
Sibeprenlimab is an investigational anti-APRIL monoclonal antibody targeting IgA nephropathy, also known as Berger’s disease. It blocks Gd-IgA1 production, a key step in the disease’s immune response.
IgA nephropathy is a chronic kidney disease that can progress to end-stage kidney disease (ESKD).
The antibody was designed and engineered by Visterra, an American subsidiary of Otsuka Pharmaceutical.
Otsuka Pharmaceutical previously received breakthrough therapy designation in February for sibeprenlimab after the positive Phase 2 ENVISION trial results.
VISIONARY is a multicentre, randomised, double-blind, placebo-controlled trial. It includes about 530 adult patients with IgA nephropathy receiving standard care.
The study evaluated the efficacy and safety of the monoclonal antibody 400mg administered subcutaneously every four weeks, focusing on changes in 24-hour uPCR (urine protein-to-creatine ratio) at nine months.
An independent data monitoring committee found that the Phase 3 trial met its primary endpoint.
Sibeprenlimab showed a statistically significant and clinically meaningful reduction in the 24-hour uPCR compared to placebo after nine months.
Otsuka Pharmaceutical development and commercialisation executive vice president and chief medical officer John Kraus said: “The positive interim data from this trial suggest that by targeting APRIL, we could provide a new therapeutic strategy for people living with this progressive kidney disease.
“We look forward to the completion of this study and reviewing the full results at a future timepoint. We are deeply appreciative to the patients with IgA nephropathy who participated in this trial, their caregivers, and investigators, all of whom continue to contribute greatly to this research.”
The ongoing Phase 3 study will continue evaluating kidney function changes over 24 months, measured by the estimated glomerular filtration rate (eGFR), and is set to complete in early 2026.
Additional prespecified and exploratory analyses will assess the full potential of sibeprenlimab for treating IgA nephropathy.
Otsuka plans to share interim analysis results with the FDA to pursue potential accelerated approval.
Recently, Otsuka Pharmaceutical signed a deal to acquire Jnana Therapeutics. Based in the US, Jnana Therapeutics is a clinical-stage biotechnology firm dedicated to developing innovative therapies targeting a broad spectrum of conditions, including rare and immune-mediated diseases.
