Via Pharmaceuticals reports positive data from Phase II cardiovascular studies

In each Phase II study, VIA-2291 inhibited production of leukotrienes, proposed mediators of vascular inflammation. VIA-2291 was generally well-tolerated, the company said.

According to the company, 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 (p<0.001). 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) (p<0.01). A third Phase II clinical trial is currently underway to measure reductions in plaque inflammation following dosing with VIA-2291 as measured with FDG-PET imaging technology and assessment of standard biomarker measurements of inflammation in patients with ACS. According to the company, 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. Lawrence Cohen, CEO of Via Pharmaceuticals, said: "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. 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."