Anthera completes enrollment in acute coronary syndrome study

Anthera’s fewer recurrent acute coronary events with near-term cardiovascular inflammation suppression (Francis) trial is based upon direct feedback from the FDA via the special protocol assessment procedure. The trial is designed to assess the impact of oral varespladib on known biological markers of cardiovascular risk. Anthera plans to enroll between 500-700 patients that will be treated for up to six months.

The study is being conducted at sites across North America and Europe. The Francis trial is expected to provide further insight into the prevention of secondary major adverse cardiovascular events (MACE) over the duration of the trial.

In this study, MACE is defined as a composite endpoint consisting of cardiovascular death, non-fatal stroke, non-fatal myocardial infarction, unstable angina, and a subset of revascularization following the initial event. During the course of the study, patients will receive therapeutic standard of care in addition to high dose Lipitor (atorvastatin).

Colin Hislop, senior vice president of clinical development at Anthera Pharmaceuticals, said: With the varespladib trial fully enrolled, we look forward to reporting the biomarker results and event trends later in 2009. Based upon the positive results from varespladib’s two previous Phase II clinical trials that demonstrated lipid-lowering and anti-inflammatory benefits, we look forward to examining the impact of varespladib on the hyper-inflammatory state presented by acute coronary syndrome patients.