AstraZeneca Plc. (NASDAQ:AZN) said its Phase 3 I CAN trial evaluating Ultomiris (ravulizumab) in adults with immunoglobulin A nephropathy (IgAN) at risk of disease progression met a prespecified interim endpoint.
The study showed a statistically significant and clinically meaningful reduction in proteinuria compared with placebo at week 34.
AstraZeneca’s Ultomiris Cuts Proteinuria
According to the interim analysis, patients treated with Ultomiris achieved a 46.6% reduction in 24-hour urine protein creatinine ratio (UPCR) from baseline, compared with a 5.6% reduction in the placebo group.
The placebo-adjusted treatment effect was 43.4%, with the result reaching statistical significance (p<0.0001).
AstraZeneca Reports Early And Sustained Response
The company said the reduction in proteinuria emerged as early as week 10 and remained consistent through week 34. At week 10, Ultomiris-treated patients recorded a 36.7% reduction in proteinuria, compared with 8.5% for placebo.
The benefit was observed across multiple patient subgroups, including individuals with varying demographic characteristics, baseline clinical profiles, and disease severity.
Jonathan Barratt, Mayer Professor of Renal Medicine at the University of Leicester and an investigator in the I CAN trial, said terminal complement activation plays a significant role in inflammation and kidney function decline in IgAN. He said the interim findings suggest that targeting the terminal complement pathway with Ultomiris may provide a disease-modifying approach for patients with the rare kidney disease.
Safety Profile Remains Consistent
Gianluca Pirozzi, Senior Vice President and Head of Development, Regulatory and Safety at Alexion, AstraZeneca Rare Disease, said the results demonstrated an early and meaningful reduction in proteinuria, including among patients at higher risk of disease progression.
He added that the findings support the role of terminal complement inhibition in IgAN and will help advance regulatory filings in key markets.
The safety profile was consistent with the known profile of Ultomiris, with no new safety concerns identified.
AZN Stock Price Activity: AstraZeneca shares were down 1.51% at $183.14 at the time of publication on Monday, according to Benzinga Pro data.
AstraZeneca-Photo by Robert Way via Shutterstock
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