Resverlogix has initiated dosing in ASSURE, a phase IIb clinical trial led by the Cleveland Clinic. ASSURE is a 26-week, multi-center, double-blind, randomized, parallel group, placebo-controlled clinical trial that will assess coronary atherosclerotic plaque changes in response to Resverlogix's lead drug RVX-208 using intravascular ultrasound (IVUS). ASSURE will examine the early effects of RVX-208 induced ApoA-I production on atherosclerotic plaque regression in the setting of patients with coronary artery disease who have a low level of high-density lipoprotein cholesterol (HDL-C). A total of 310 patients are expected to participate in ASSURE of which 77 will receive placebo and 233 will be given 100 mg twice daily of RVX-208.
An IVUS measurement will be taken prior to the first dose of RVX-208 and this will be repeated after 26 weeks of treatment. The primary trial endpoint will be IVUS measurement of a change in percent atheroma volume from baseline to 26 weeks. Secondary objectives for ASSURE are: safety and tolerability of RVX-208 as reflected by adverse events, and effects of RVX-208 on HDL and non-HDL lipid parameters.