CSL's ACS drug achieves mixed results in trial

Australian specialty biopharmaceutical firm CSL says that infusions of its agent CSL-111, in an effort to increase high-density lipopolysaccharide levels, may reduce arterial plaque in patients who have suffered a recent episode of acute coronary syndrome. The data were presented at the American College of Cardiology's annual meeting, having been published in the Journal of the American Medical Association.

The Phase II ERASE study, which was conducted at 17 sites throughout Canada under the leadership of the Montreal Heart Institute, was designed to examine the impact of four weekly infusions of the drug on coronary plaque volume in patients with a recent ACS episode. Initially, subjects were randomized to receive one of two doses of the drug (40mg/kg or 80mg/kg) or placebo, and were assessed using a combination of intravascular ultrasound and quantitative coronary angiography. However, the higher dosage was discontinued early due to transient liver function abnormalities.

The results showed that the 40mg/kg dose cut plaque volume an average 3.4%, compared with placebo where the reduction was 1.6%. The firm added that, although this difference was not significant, when each was compared with baseline readings the reduction in plaque volume brought about by the 40mg/kg dose did represent a statistically-significant decrease, whereas the placebo did not.