VIA Announces Positive Results of Phase 2 Studies of VIA-2291 in Patients with Serious Cardiovascular Disease
News Nov 10, 2008
VIA Pharmaceuticals, Inc. has announced the results of two Phase 2 studies of its lead drug, VIA-2291. In each Phase 2 study, VIA-2291 effectively inhibited production of leukotrienes, proposed mediators of vascular inflammation.
VIA-2291 was generally well-tolerated. The results were presented today during a Special Session at the American Heart Association 2008 Scientific Sessions being held in New Orleans.
"These trials accomplished our goal of demonstrating that VIA-2291 directly impacts the leukotriene pathway and potentially reduces vascular inflammation, which we believe leads to atherosclerosis and death in a broad population," said Lawrence K. Cohen, Ph.D., chief executive officer of VIA Pharmaceuticals. "We now look forward to designing studies that can link VIA- 2291's unique mechanism of action to improvement in atherosclerotic plaque and ultimately cardiovascular outcomes."
The first of these trials, the acute coronary syndromes (ACS) trial, met its primary endpoint by demonstrating a significant change from baseline in Leukotriene B4 (LTB4) production at all doses tested.
The second trial, the carotid endarterectomy (CEA) trial, missed its primary endpoint of percentage reduction in macrophage inflammatory cells in plaque tissue, but met key secondary endpoints including reduction of high sensitivity C-reactive protein (hs-CRP).
"VIA-2291 has the potential to be the first drug to specifically target one cardiovascular inflammatory pathway," said Dr. Jean-Claude Tardif, Director of the Montreal Heart Institute Research Centre, professor of medicine at the University of Montreal and principal investigator of the VIA- 2291 ACS trial. "These data support further clinical development of this drug, including larger outcome trials."
Cardiologists have several therapies that help reduce heart disease risk factors, but none that specifically targets inflammation, an underlying cause of atherosclerosis, which leads to major adverse cardiac events, including heart attack and stroke.
VIA-2291 is designed to be a selective and reversible inhibitor of 5-LO, a key enzyme in the biosynthesis of leukotrienes, that are important mediators of inflammation believed to be involved in the development and progression of atherosclerosis.
The cholesterol-lowering drugs called statins have demonstrated substantial benefits in reducing the risk of heart attacks and strokes caused by blood clots (ischemic strokes) in at-risk patients. Since statins are associated with a low risk of side effects, the benefits of taking them outweigh the risks, according to a scientific statement from the American Heart Association that reviewed multiple studies evaluating the safety and potential side effects of these drugs.READ MORE
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