Otsuka Pharmaceutical has shared positive results from a late-stage study of its investigational monoclonal antibody sibeprenlimab in adults with the rare kidney disease immunoglobulin A nephropathy (IgAN).
The phase 3 VISIONARY study, which Otsuka said is the largest IgAN trial to date, has been comparing the candidate against placebo in approximately 510 patients who were receiving standard-of-care therapy.
IgAN occurs when the IgA protein accumulates in the kidneys and damages them. This impedes their filtering function and, as a result, the kidneys start to let substances such as blood and protein leak into the urine. The disease typically appears in adults aged 20 to 40 years and can lead to end-stage kidney disease over the lifetime of most patients.
Results presented at this year’s European Renal Association Congress showed that patients treated with sibeprenlimab, administered subcutaneously every four weeks, achieved a 51.2% reduction in excess protein in the urine (proteinuria) compared to placebo at nine months.
The safety profile of sibeprenlimab was also found to be favourable and consistent with previously reported data, Otsuka said, with 76.3% of sibeprenlimab-treated patients experiencing any treatment emergent adverse event compared to 84.5% in the placebo group.
John Kraus, executive vice president and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, said: “Proteinuria control is an important independent predictor for long-term prognosis, and this interim data reinforces our belief that selectively targeting APRIL [a cytokine in the tumour necrosis factor family] has the potential to be an effective and safe approach for this progressive and irreversible kidney disease.”
VISIONARY will continue to evaluate change in kidney function over two years, as measured by estimated glomerular filtration rate, and is expected to be completed early next year.
Sibeprenlimab has already been granted Priority Review designation by the US Food and Drug Administration, with a target action date of 28 November 2025.
“The safety data emerging from VISIONARY is reassuring and adds to our existing knowledge about sibeprenlimab’s safety profile from prior programmes,” said Dana Rizk, professor of medicine in the division of nephrology at the University of Alabama at Birmingham. “This is very exciting news for patients and adds a therapeutic option with a novel mechanism of action potentially targeting the immunologic pathogenesis of IgAN.”
