Novo Nordisk moves chronic kidney disease drug ziltivekimab into phase 3

Novo Nordisk has announced plans to move its ziltivekimab into phase 3 clinical development in atherosclerosis with chronic kidney disease after a mid-stage trial met its main goal.

The Danish pharma said the phase 2 RESCUE trial showed a significant reduction of several inflammatory biomarkers associated with atherosclerosis in people with advanced chronic kidney disease (CKD).

Results suggest Novo Nordisk was on the right track with its $2.1 billion acquisition of Corvidia Therapeutics in June last year,

The deal saw the firm begin to explore new markets after making its name in diabetes, a market which is being squeezed by pricing pressures.

Patients in the study were also presenting with elevated high-sensitivity C-reactive protein (hsCRP), showing they are at high cardiovascular risk.

Treatments are limited for this form of atherosclerosis, with options including cholesterol-lowering drugs and extra medications for fluid retention or heart failure.

Data were announced at the virtual American College of Cardiology annual conference and published simultaneously in The Lancet.

Atherosclerosis, the build-up of fats, cholesterol and other substances in the artery walls, is the major cause of cardiovascular disease including heart attack and stroke.

Ziltivekimab works by inhibiting the cellular transmitter IL-6,  which promotes inflammation and is thought to play a causal role in atherosclerosis.

The RESCUE trial met its primary endpoint, showing that after 12 weeks, median levels of hsCRP were significantly reduced with ziltivekimab compared with placebo.

Results showed 77%, 88% and 92% reduction in those receiving 7.5 mg, 15 mg and 30 mg of ziltivekimab, respectively, compared to 4% for placebo.

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, the company said in a statement.

Martin Holst Lange, executive vice president for development at Novo Nordisk, said: “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.”

RESCUE is a phase 2, randomised, double-blind, placebo-controlled clinical trial assessing the effect of once-monthly subcutaneous ziltivekimab on biomarkers of inflammation in people with advanced CKD and elevated hsCRP.

The study, which enrolled 264 participants, was designed to assess if ziltivekimab can safely and effectively reduce levels of inflammatory biomarkers relevant to atherosclerosis.

The pre-specified primary endpoint was change in hsCRP after 12 weeks of treatment, with additional data on safety and other inflammatory biomarkers (fibrinogen, serum amyloid A, haptoglobin and secretory phospholipase A2) collected over 24 weeks of treatment.