Resverlogix Corp. has announced that it has completed enrollment in ASSURE, a Phase 2b clinical trial targeting high-risk cardiovascular disease patients.
ASSURE will evaluate the ability of RVX-208, Resverlogix's BET protein inhibitor, to regress atherosclerotic disease versus placebo using intravascular ultrasound (IVUS) technology in patients with coronary artery disease (CAD).
"Completing enrollment of the ASSURE clinical trial marks another major milestone for Resverlogix as we aim to demonstrate the efficacy of RVX-208 in atherosclerotic plague regression," stated Donald McCaffrey, president and chief executive officer of Resverlogix.
McCaffrey continued, "RVX-208 stimulates production of ApoA-I, increasing the functional HDL particles required for reverse cholesterol transport. We expect to announce top-line data from ASSURE in H1 2013."
ASSURE is a 26-week, multi-center, double-blind, randomized, parallel group, placebo-controlled clinical trial led by the Cleveland Clinic.
The primary trial endpoint will be measurement of atheroma volume reduction from baseline to 26 weeks measured by IVUS.
Secondary objectives for ASSURE are evaluating the safety and tolerability of RVX-208 and effects of RVX-208 on HDL and non-HDL lipid parameters.
Using IVUS data, we will also assess changes in plaque stability, an important factor affecting risk of myocardial infarction.