Anthera Announces Positive Results From Cardiovascular Trial
Anthera Pharmaceuticals reported preliminary results of a second Phase IIb clinical trial of A-002, for the treatment of cardiovascular disease. In this second study, administration of once-daily A-002 lowered both sPLA2 and LDL-C levels confirming the positive effects of A-002 treatment seen in the twice-daily PLASMA study (Phospholipase Levels And Serological Markers of Atherosclerosis) announced in October 2007.
The second trial was a multi-center, randomized, double-blind, placebo-controlled trial that enrolled approximately 140 patients with stable coronary heart disease in the U.S. Subjects were randomized to receive one of two different daily doses of A-002 or placebo for up to eight weeks. Patients also received doctor-determined standard of care therapies. The primary endpoint was reduction in secretory phospholipase A2 (sPLA2) levels. Secondary endpoints included a number of lipid and inflammatory biomarkers. The Company plans to present data from the Phase IIb trial at scientific meetings in 2008.
"We are extremely pleased to validate the findings of our first PLASMA study, with once-a-day dosing of A-002 which further enhances our development and commercial flexibility," said Paul F. Truex, President and Chief Executive Officer of Anthera Pharmaceuticals, Inc. "We look forward to meeting with the FDA to discuss our plans for Phase III. We expect the registration program will target patients with coronary heart disease with associated hyperlipidemia and inflammation who are currently not achieving adequate cholesterol control with diet, exercise, and existing statin therapies such as Lipitor."
Data from the first PLASMA trial demonstrated that in addition to lowering sPLA2, treatment with A-002 resulted in significant reductions in blood levels of total cholesterol, Non-High Density Lipoprotein Cholesterol (non HDL-C), and Low Density Lipoprotein Cholesterol (LDL-C), known as "bad" cholesterol, oxidized LDL, and apolipoprotein-B100 (Apo-B) coupled with equally meaningful reductions of C-Reactive Protein (CRP), a recognized marker of inflammation and possible cardiovascular risk. Decreases in these levels with A-002 treatment were most significant among patients already on a background of statin therapy.