Novo Nordisk Phase 2 med cut inflammatory biomarkers tied to atherosclerosis in chronic kidney disease

 Novo Nordisk today presented results from RESCUE, a  phase 2 randomised, double-blind, placebo controlled clinical trial assessing the effect of once-monthly, investigational ziltivekimab, an interleukin-6 (IL-6) inhibitor, on biomarkers of inflammation. The trial showed a significant reduction of multiple inflammatory biomarkers associated with atherosclerosis in people with advanced chronic kidney disease (CKD) and elevated high-sensitivity C-reactive protein (hsCRP), representing high cardiovascular risk. The data were announced today at the virtual American College of Cardiology's (ACC) 70th Annual Scientific Session1 and simultaneously published in The Lancet2.

Atherosclerosis is the major cause of cardiovascular disease (CVD), including heart attack and stroke3. Atherosclerosis is characterised by the build-up of fats, cholesterol and other substances in the artery walls that results in vessel narrowing and reduced blood flow3. Chronic inflammation contributes to the development and progression of atherosclerosis4, and biomarkers for inflammation, such as hsCRP, can be used to predict cardiovascular risk5.

The RESCUE trial met its primary endpoint, showing that after 12 weeks, median levels of hsCRP were significantly reduced with ziltivekimab compared with placebo (77%, 88% and 92% reduction in those receiving 7.5 mg, 15 mg and 30 mg of ziltivekimab, respectively, compared to 4% for placebo). The proportion of people achieving both a greater than 50% reduction in hsCRP and hsCRP levels of less than 2 mg/L, a secondary endpoint, was also significantly higher with ziltivekimab than placebo (66%, 80% and 93% in those receiving 7.5 mg, 15 mg and 30 mg of ziltivekimab, respectively, compared to 4% for placebo). Dose-dependent reductions were also observed for four additional inflammatory biomarkers (fibrinogen, serum amyloid A, haptoglobin and secretory phospholipase A2). Treatment emergent adverse events were considered to be mild, moderate, or severe and were similar between the placebo and ziltivekimab groups. Ziltivekimab was generally well tolerated, with no unexpected side effects2.

https://www.prnewswire.com/news-releases/ziltivekimab-reduced-inflammatory-biomarkers-associated-with-atherosclerosis-in-people-with-chronic-kidney-disease-in-phase-2-trial-301292574.html