Resverlogix has finished enrolling high-risk cardiovascular disease patients in its 26-week, multi-centre, double-blind Phase IIb ASSURE trial of RVX-208, a BET protein inhibitor.
ASSURE is designed to evaluate the ability of RVX-208 to regress atherosclerotic disease versus placebo using intravascular ultrasound (IVUS) technology in patients with coronary artery disease (CAD).
Resverlogix president and CEO Donald McCaffrey said the company aims to demonstrate RVX-208's efficacy in atherosclerotic plague regression.
"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," McCaffrey said.
The primary endpoint of the randomised, parallel group trial is the measurement of atheroma volume reduction from baseline to 26 weeks, measured by IVUS.
Secondary objectives of the placebo-controlled trial are the safety and tolerability of RVX-208, and effects of RVX-208 on HDL and non-HDL lipid parameters.
The IVUS data will be used to assess the changes in plaque stability, a vital factor affecting risk of myocardial infarction.
RVX-208 is a small molecule that inhibits BET bromodomains and functions by removing atherosclerotic plaque via reverse cholesterol transport (RCT), the natural process which aids atherosclerotic plaque transportation out of the arteries and removes from the body by the liver.
The drug candidate, which has the potential to treat neurodegenerative disorders, increases production of ApoA-I, the key building-block of functional high-density lipoprotein (HDL) particles, and the type required for RCT.