Canadian biopharmaceutical company Resverlogix has commenced a Phase II clinical trial for RVX-208, its small molecule therapy for the treatment of atherosclerosis in patients with stable coronary artery disease. The Cleveland Clinic was the first medical center to begin dosing patients in the ASSERT (ApoA1 Synthesis Stimulation Evaluation in Patients Requiring Treatment for Coronary Artery Disease) trial. The 18-week study will eventually involve about 280 patients at 40 medical centers across the U.S.
The primary endpoint of the study is to determine whether RVX-208 produces an increase in ApoA1 levels compared to placebo after three months. ApoA1 is a protein that helps reverse plaque buildup in the arteries. If plaque buildup becomes severe enough, atherosclerosis (or “hardening of the arteries”) can result. Atherosclerosis is a major underlying cause of cardiovascular disease, the leading cause of death in the U.S.
While statin drugs can halt the progress of atherosclerosis, there is no currently available treatment to reverse it. If approved, RVX-208 would be the first marketed therapy for the regression of atherosclerosis. VIA Pharmaceuticals, BioInvent and CytoTools are three other companies developing therapies to treat this potentially life-threatening condition.