VIA’s lead compound: VIA-2291
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 is initially targeted to address the secondary prevention market for patients who have already suffered a major adverse cardiac event, but eventually 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. Based upon prior trials of VIA-2291 in more than 1,100 patients, VIA believes that VIA-2291 will be safe and well tolerated in doses currently being administered in the ongoing clinical trials.
Phase 2 Clinical Trial Program
VIA-2291 is being studied in three Phase 2 clinical trials with novel study designs aimed at providing proof-of-concept as early as possible in the clinical development process.
The Company has 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 multidetector 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 Company completed enrollment in its third Phase 2 clinical trial of VIA-2291, the FDG-PET Trial – – that utilizes Positron Emission Tomography with fluorodeoxyglucose tracer (FDG-PET) to measure the impact of VIA-2291 on reducing plaque inflammation in treated patients. The Company has 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 is being run at clinical sites in the United States and Canada. Endpoints in the study include reduction in plaque inflammation as measured with FDG-PET, as well as assessment of standard biomarker measurements of inflammation. The FDG-PET clinical trial is expected to report data in the second half of 2009.
