Cardiovascular Drugs
VIA-2291 Targets the 5-LO Pathway
VIA-2291 is a selective and reversible inhibitor of 5-LO, which is a key enzyme in the biosynthesis of leukotrienes (important mediators of inflammation involved in the development and progression of atherosclerosis). Potentially a complement to current standard of care therapies that treat risk factors, such as statins, antiplatelet and blood pressure medications, VIA-2291 could be beneficial to more than 15 million patients who suffer from atherosclerosis and cardiovascular disease. VIA has exclusive worldwide rights to develop and commercialize VIA-2291.
Phase 2 Clinical Trial Program
VIA-2291 was studied in three Phase 2 clinical trials with novel study designs aimed at providing evidence of plaque modification and systemic anti-inflammatory effects as early as possible in the clinical development process.
VIA completed the Phase 2 ACS Trial in 191 patients at 15 clinical sites in the United States and Canada for patients with Acute Coronary Syndrome (ACS) who experienced a recent heart attack. In addition, the Company has completed the Phase 2 CEA Trial of VIA-2291 at clinical sites in Italy for patients who underwent a carotid endarterectomy (CEA).
Results from the CEA and ACS Phase 2 trials were presented at the American Heart Association (AHA) 2008 Scientific Sessions on November 9, 2008. A sub-study of over 85 patients in the ACS Phase 2 trial elected to continue in the study for an additional 12 weeks, receiving either placebo of VIA-2291 on top of standard medical care. Following treatment these patients received a 64 slice multi-detector computed tomography (MDCT) scan which was compared to a baseline scan. Results of this sub-study were presented May 2009 at the AHA Arteriosclerosis, Thrombosis and Vascular Biology Annual Conference 2009. The results of the ACS study are published in Circulation Cardiovascular Imaging by lead author and principal investigator Jean-Claude Tardif (2010;3:298-307).
VIA completed its third Phase 2 clinical trial of VIA-2291, the FDG-PET Trial – – an experimental non-invasive imaging technique that utilizes Positron Emission Tomography with fluorodeoxyglucose tracer (FDG-PET) to measure the impact of VIA-2291 on reducing FDG uptake into vascular beds. The Company enrolled 52 patients following an Acute Coronary Syndrome event, such as heart attack or unstable angina, into the 24 week, randomized, double blind, placebo-controlled study, which was run at clinical sites in the United States and Canada.
Overall the studies demonstrated potent dose-dependent inhibition of Leukotrienes B4 and E4 by VIA-2291. Systemic and plaque anti-inflammatory effects were observed including statistically significant inhibition of hsCRP with the 100 mg dose. Inflammatory genes in unstable plaques were down-regulated with VIA-2291 treatment. Serial multi-detector Computed Tomography indicated a statistically significant reduction in non-calcified plaque volume and the number of patients developing new coronary lesions with VIA-2291 treatment.
