The acute coronary syndrome (ACS study), which enrolled 191 patients, is designed to establish dose and safety data in patients with ACS who have experienced a recent heart attack or unstable angina. The study includes measures of leukotrienes, biomarkers of inflammation, as well as medical imaging of the coronary vessels to evaluate the impact on plaque characteristics in a subset of patients. Patients in the study are treated once daily with one of three dose levels of VIA-2291 or placebo.
This is the second Phase II study of VIA-2291 to complete enrollment. In March 2008, Via announced completion of enrollment in its carotid endarterectomy (CEA) trial, which is designed to provide direct evaluation of VIA-2291’s effect on inflammation by analyzing plaque removed from the carotid arteries in patients treated with VIA-2291 or placebo. Enrollment in the third Phase II clinical trial, the FDG-PET Trial, is ongoing.
VIA-2291 is a potent small molecule drug that targets inflammation in the blood vessel wall, a primary disease process in atherosclerosis. It is being developed as a once-daily, oral drug to potentially decrease the risk of major adverse cardiac events associated with inflammation, including heart attack and stroke.
Via expects to report top line results from the ACS trial soon after top line CEA study results are presented in the third quarter of 2008.