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AstraZeneca hails phase 3 trial results of inhibitor Ultomiris

ALN

AstraZeneca PLC on Saturday announced new data on its kidney disease treatment Ultomiris.

The Cambridge, England-based pharmaceutical company said in I CAN phase 3 trial data, Ultomiris, or ravulizumab, showed a statistically significant and clinically meaningful reduction in proteinuria from baseline, based on 24-hour urine protein creatinine ratio [UPCR], compared to a placebo at week 34 in adults with immunoglobulin A nephropathy [IgAN] who are at risk of disease progression.

IgAN is a rare inflammatory disease of the kidneys that can lead to chronic kidney disease and progress to end-stage kidney disease.

Pertinently, Ultomiris demonstrated a 46.6% reduction in 24-hour UPCR from baseline at week 34, compared to 5.6% in patients receiving placebo, resulting in a placebo-adjusted treatment effect of 43.4%.

AstraZeneca highlighted that the reduction in proteinuria was rapid, observed as early as week 10 with Ultomiris, and sustained through 34 weeks, compared to placebo.

Ultomiris inhibits the C5 protein in the terminal complement cascade, a part of the body’s immune system. AstraZeneca said: ‘When activated in an uncontrolled manner, the complement cascade over-responds, leading the body to attack its own healthy cells.’

Jonathan Barratt, Mayer Professor of Renal Medicine, University of Leicester, and I CAN trial investigator, said: ‘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. These interim results show that by targeting the terminal complement pathway, Ultomiris delivered a rapid and significant reduction in proteinuria supporting its potential as a disease-modifying treatment for people living with this devastating rare disease.’

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