Anthera Announces Preliminary Positive Results From Once-DailyA-002 Phase II Cardiovascular Trial
SAN MATEO, Calif., January 15, 2008 /PRNewswire/ -- Anthera Pharmaceuticals, Inc., a privately-held biopharmaceutical company, 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(R)."
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.
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.Â? 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 leukotrienesÂ? prostacyclins and other mediators of inflammation. These highly potent compounds inhibit novelÂ? 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.
Contact: Anne Bowdidge (650) firstname.lastname@example.org
CONTACT: Anne Bowdidge of Anthera Pharmaceuticals, Inc., +1-650-218-6900, email@example.com
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Posted: January 2008