Anthera Pharmaceuticals, Inc., a privately held biopharmaceutical company developing anti-inflammatory drugs for chronic and acute diseases, announced that enrolment has begun in the company's multi-centre phase 2 clinical trial (PLASMA - Phospholipase Levels And Serological Markers of Atherosclerosis).
PLASMA is a double-blind, randomized, parallel group, placebo controlled study among subjects with stable coronary artery disease (CAD). Subjects will be randomized to receive either placebo tablets or one of four orally active doses of A-002. A-002 is a potent inhibitor of secretory phospholipase A2 (s) - a family of enzymes which lead to the release of damaging free fatty acids and lysophospholipids, both of which play a role in the inflammatory process. The duration of study drug therapy will be eight weeks and approximately 200 patients in 60 sites in the US and Europe will be enrolled.
"This multi-centre study is an important aspect of our comprehensive development strategy for our lead cardiovascular compound A-002," commented James Pennington, M.D. Executive Vice President and Chief Medical Officer. "This strategy involves multiple clinical studies and a comprehensive non-clinical program with the goal of providing a new therapeutic approach targeting both vascular inflammation and atherogenic lipid profiles in a large cardiovascular patient population."
There is a growing body of literature implicating s in the development of atherosclerosis and increased risk of cardiovascular events. In addition to causing vascular inflammation, s is known to have adverse effects on high density lipoproteins (HDL) or so called "good cholesterol", while potentially increasing levels of low density lipoproteins (LDL) or "bad cholesterol". The first data demonstrating the effectiveness of A-002 in treating atherosclerosis in a standard animal model are scheduled to be presented at the Eight Congress on Inflammation, June 16th - 20th, 2007 in Copenhagen, Denmark.