Anthera, Inc. Announces Positive Phase II Clinical Results From A-002 Cardiovascular Disease Trial
SAN MATEO, Calif., Oct. 24 /PRNewswire/ -- Anthera Pharmaceuticals, Inc., a privately-held biopharmaceutical company, reported results of a Phase II clinical trial of its first compound, A-002, for the treatment of cardiovascular disease. The trial results suggest that 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, coupled with equally meaningful reductions of C-Reactive Protein (CRP), a recognized marker of inflammation and cardiovascular risk. Decreases in these levels with A-002 treatment were most significant among patients already on a background of statin therapy.
The Phase II PLASMA trial (Phospholipase Levels And Serological Markers of Atherosclerosis) was a multi-center, randomized, double-blind, placebo- controlled trial that enrolled approximately 400 patients with stable coronary heart disease in the U.S. and Ukraine. Subjects were randomized to receive one of four different doses of A-002 or placebo for up to eight weeks. Patients also received doctor-determined standard of care therapies. The primary endpoint, a reduction in secretory phospholipase A2 (sPLA2) levels was achieved with a high degree of statistical significance. In addition, the results also demonstrated clinically meaningful as well as statistically significant decreases in cholesterol levels (LDL-C, non-HDL and total cholesterol) in patients with stable coronary heart disease. Clinically meaningful decreases in inflammation, as measured by levels of CRP, were also observed in the relevant patient population. Full data will be presented in a scientific journal during 2008.
"The results of the PLASMA trial support our belief that A-002's unique mechanism of action has a dual effect on lipids and inflammation, which could provide significant therapeutic benefit to patients currently on background statin therapy," said Paul F. Truex, President and Chief Executive Officer of Anthera Pharmaceuticals. "Importantly, based upon these results, we will propose utilizing metabolic endpoints for our Phase III program, which may warrant smaller trials based on improvements in cholesterol and markers of inflammation."
"This trial revealed that A-002 treatment resulted in significant positive changes on lipoproteins and inflammation, major etiological factors that lead to atherosclerosis among cardiovascular patients treated with statins," said Dr. Robert Rosenson, Director of Lipoprotein Disorders and Clinical Atherosclerosis Research at the University of Michigan and lead investigator for the PLASMA trial. "Of particular interest was the marked reduction in small LDL particles that are associated with the development of atherosclerosis."
The company expects to meet with the FDA in December to discuss the results of the trial and plans for Phase III. At present, Anthera anticipates the A-002 Phase III 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(R). PLASMA-2, the once-daily Phase II trial of A-002, has completed enrollment and data is expected in the first quarter of 2008.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a privately-held company committed to developing and commercializing clinical pharmaceutical products that address unmet medical needs of patients with life-threatening, chronic and acute inflammatory diseases. The Company has acquired from Eli Lilly and Company and Shionogi & Co.? Ltd. worldwide rights (excluding Japan) to a series of clinical and pre-clinical compounds that inhibit the enzymatic activity of members of the phospholipase A2 (PLA2) family - a group of enzymes responsible for the release of arachidonic acid and subsequent production of leukotrienes? prostacyclins and other mediators of inflammation. These highly potent compounds inhibit novel? upstream steps in the inflammation cascade and have the potential to address a variety of diseases. For more information, please visit http://www.anthera.com.