AstraZeneca announces I CAN Phase III trial of Ultomiris met primary endpoint

AstraZeneca (AZN) announces “positive high-level results” from a prespecified interim analysis of the I CAN Phase III trial showed that Ultomiris met its primary endpoint, demonstrating a statistically significant reduction of proteinuria, based on 24-hour urine protein creatinine ratio, at week 34 in adults with immunoglobulin A nephropathy who are at risk of disease progression. The primary endpoint of change from baseline in estimated glomerular filtration rate will be measured at week 106. Jonathan Barratt, MD, Mayer Professor of Renal Medicine, University of Leicester, United Kingdom, and I CAN trial investigator, said: “Many people living with IgAN continue to progress to kidney failure, ultimately requiring dialysis or a transplant – outcomes that can place profound burden on patients’ daily lives – despite advances in care. The interim I CAN results demonstrate that blocking terminal complement activation, a central driver of kidney inflammation in IgAN, with Ultomiris may play a promising role in reducing proteinuria. We look forward to understanding the full clinical impact of Ultomiris in treating this disease following study completion at two years.”