Resverlogix has announced that it has completed enrolment 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 arterial disease (CAD).
ASSURE is a 26-week, multicentre, double-blind, randomised, 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.
“Completing enrolment 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,” said Donald McCaffrey, president and chief executive officer of Resverlogix. “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 the first half of 2013.”
RVX-208 is a first-in-class, small molecule that inhibits BET bromodomains. It is currently in clinical study for the treatment of atherosclerosis. RVX-208 functions by removing atherosclerotic plaque via reverse cholesterol transport (RCT), the natural process through which atherosclerotic plaque is transported out of the arteries and removed from the body by the liver.
RVX-208 increases production of ApoA-I, the key building block of functional high-density lipoprotein (HDL) particles and the type required for RCT. Because they are newly produced, these functional HDL particles are flat and empty and can efficiently remove plaque and stabilise or reverse atherosclerotic disease. RVX-208 is currently being evaluated in phase 2b studies for its ability to reverse and/or stabilise atherosclerotic disease. The drug candidate also has the potential to treat other indications, including neurodegenerative disorders.