Novo Nordisk has presented results from the 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, states the company in a press release.
“We are very encouraged by these promising phase 2 data, which is an important step towards a new potential anti-inflammatory treatment approach for people living with atherosclerotic CVD and CKD,” says Martin Holst Lange, executive vice president for Development at Novo Nordisk. “Based on these results, we are planning to progress ziltivekimab to a large-scale phase 3 cardiovascular outcomes trial to further assess its potential, as we continue to advance our commitment in cardiovascular disease.”
The RESCUE trial
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 effects.
Photo of Martin Holst Lange: Novo Nordisk