CEA Trial
The Phase 2 CEA Trial was completed after enrollment 50 patients with significant carotid artery stenosis (narrowing) who elected to undergo a carotid endarterectomy (CEA).
A CEA is a surgical procedure to remove plaque in the lining of the carotid artery to allow normal blood flow to the brain. Patients in the study were treated once daily with 100mg of oral VIA-2291 or placebo for three months prior to surgery. Investigators evaluated atherosclerotic plaque tissue from the surgical procedures for evidence of VIA- 2291’s effect on plaque morphology, cellular composition, protein and gene expression. The study also included measures of leukotrienes and serum biomarkers of inflammation. The CEA study was designed to examine the impact of VIA-2291 on plaque inflammation, and had the unique advantage of providing access to atherosclerotic plaque tissue for direct evaluation through a panel of assays and histological examinations. Data from this trial was reported at the November 2008 AHA 2008 Scientific Sessions. The 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). VIA-2291 was generally well-tolerated. Exploratory endpoints demonstrated that inflammatory genes in unstable plaques are down-regulated and plaque necrotic core was reduced with VIA-2291 treatment.