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 currently 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 enrollment of 50 patients in the Phase 2 CEA Trial of VIA-2291 at clinical sites in Italy for patients who will undergo a carotid endarterectomy (CEA). In addition, the Company is nearing full enrollment of approximately 200 patients in the second Phase 2 ACS Trial at 15 clinical sites in the United States and Canada for patients with acute coronary syndrome (ACS) who experienced a recent heart attack.
The Company currently anticipates that it will report CEA data in the third quarter of 2008. The ACS trial is expected to complete enrollment in the near future and data is expected to report shortly after the CEA trial data is reported.
In October 2007, the Company’s Data Safety Monitoring Board (DSMB) performed a review of both safety and efficacy data related to the Company’s CEA and ACS clinical trials to determine the progress in the clinical program and the patient safety of VIA-2291. Based on this review, the DSMB observed a continued acceptable safety profile and evidence of a consistent pharmacological effect of VIA-2291 as would be predicted given its proposed mechanism of action. The DSMB recommended the studies continue as planned.
Following the results of the DSMB review, the Company decided to begin enrolling patients in a third additional Phase 2 clinical trial – the FDG-PET Trial – that utilizes Positron Emission Tomography with fluorodeoxyglucose tracer (FDG-PET) to measure the impact of VIA-2291 on reducing vascular inflammation in treated patients. The Company plans to enroll approximately 50 patients following an acute coronary syndrome event, such as heart attack or stroke, into the 24 week, randomized, double blind, placebo-controlled study, which will be run at four clinical sites in the United States. Endpoints in the study will 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 be completed in 2008 and data reported in the first half of 2009.
In April, 2008, the Company announced that another meeting of the DSMB verified a continued acceptable safety profile of VIA-2291 and recommended VIA continue its ongoing trials as planned.
