The multi-national Phase IIa trial of ARC1779 is expected to enroll approximately 300 patients. The trial is a dose-ranging, randomized, double-blind study using ReoPro as a comparator. The co-primary efficacy endpoints of the trial will be the degree of myocardial perfusion and the deficit of blood supply to the working heart muscle, or myocardial ischemia, after PCI.
The primary safety endpoint is bleeding, which will be measured by clinical observation. Archemix also plans to use biomarkers to measure the extent of heart damage suffered by patients as well as the activation of the clotting system.
ARC1779 is an aptamer designed to bind to and inhibit the function of the protein known as von Willebrand Factor, or vWF. vWF initiates and promotes platelet clot formation in the arterial circulation of patients with ACS.