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AstraZeneca's Ultomiris shows 46.6% reduction in kidney protein levels

June 8, 2026 3:02 AM

AstraZeneca (NASDAQ: AZN) reported positive interim results from its Phase III trial evaluating Ultomiris for immunoglobulin A nephropathy, a rare kidney disease. The trial showed a statistically significant reduction in proteinuria compared to placebo.

The I CAN trial demonstrated that Ultomiris reduced 24-hour urine protein creatinine ratio by 46.6% from baseline at week 34, compared to 5.6% in patients receiving placebo. This resulted in a placebo-adjusted treatment effect of 43.4%, according to the company's statement.

The reduction in proteinuria appeared as early as week 10, with Ultomiris showing a 36.7% decrease compared to 8.5% for placebo. The effect remained sustained through 34 weeks and was consistent across patient subgroups with varying demographic and clinical characteristics.

"For patients with IgAN, terminal complement activation is a key driver of inflammation and progressive loss of kidney function, which can frequently result in end-stage kidney disease," said Jonathan Barratt, trial investigator and professor at University of Leicester.

The safety profile was consistent with the known profile of Ultomiris, with no new safety concerns identified. Common adverse events in the treatment group included upper respiratory tract infection (11.3%), nasopharyngitis (9.2%) and infusion-related reactions (8.4%).

The results were presented at the 63rd European Renal Association Congress in Glasgow, Scotland. The trial's primary endpoint measuring estimated glomerular filtration rate will be assessed at week 106.

AstraZeneca indicated it plans to advance regulatory filings for approval in key markets based on these interim data.

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