Novo Nordisk has reported results from the Phase II RESCUE clinical trial of ziltivekimab, which substantially lowered various inflammatory biomarkers linked to atherosclerosis in advanced chronic kidney disease (CKD) patients.
The trial included people with increased high-sensitivity C-reactive protein (hsCRP), which indicates great cardiovascular risk.
A fully human monoclonal antibody, ziltivekimab can potentially reduce systemic inflammation by hindering interleukin-6 (IL-6) that has a vital role in atherosclerosis.
The randomised, double-blind, placebo-controlled Phase II trial analysed once-monthly subcutaneous ziltivekimab dose’s impact on inflammation biomarkers in advanced CKD patients with high hsCRP.
It enrolled 264 subjects and checked whether ziltivekimab could safely and effectively lower inflammatory biomarker levels significant to atherosclerosis.
Data showed that the trial met its primary endpoint with the median hsCRP levels substantially lowered in those receiving the treatment as against placebo after 12 weeks.
A 77%, 88% and 92% drop in median hsCRP levels was observed in subjects who were given 7.5mg, 15mg and 30mg of ziltivekimab, respectively, versus 4% in the placebo arm.
Furthermore, on the trial’s secondary endpoint, the proportion of subjects attaining more than 50% reduction in hsCRP and hsCRP levels below 2mg/L was greater in ziltivekimab group versus placebo.
In this trial, dose-dependent decreases were noted for four more inflammatory biomarkers -fibrinogen, serum amyloid A, haptoglobin and secretory phospholipase A2.
Novo Nordisk Development executive vice-president Martin Holst Lange said: “We are very encouraged by these promising Phase II data, which is an important step towards a new potential anti-inflammatory treatment approach for people living with atherosclerotic CVD and CKD.
“Based on these results, we are planning to progress ziltivekimab to a large-scale Phase III cardiovascular outcomes trial to further assess its potential, as we continue to advance our commitment in cardiovascular disease.”
In March this year, Novo Nordisk and Gilead Sciences agreed to expand their clinical collaboration in non-alcoholic steatohepatitis to conduct a larger trial.