Resverlogix Corp. has announced that its Phase 2b ASSURE clinical trial evaluating RVX-208 in high-risk cardiovascular patients with low high-density lipoprotein (HDL) did not meet its primary endpoint of a -0.6% change in percent atheroma volume as determined by intravascular ultrasound (IVUS). The RVX-208 treated group had -0.4% plaque regression (p= 0.08).
RVX-208 is Resverlogix's first-in-class orally active BET bromodomains inhibitor. 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.
These newly produced, functional HDL particles are flat and empty and can efficiently remove plaque and stabilize or reverse atherosclerotic disease. ApoA-I may also exert beneficial effects in Alzheimer's disease and Diabetes Mellitus.
The patient group receiving active treatment met the secondary endpoints of regression of total (coronary) atheroma volume (TAV) and increases in Apolipoprotein A-I (ApoA-I) and HDL cholesterol. Unexpected strong placebo results will need to be further explored.
ASSURE, a 26-week, multi-center, double-blind, randomized, parallel group, placebo-controlled trial enrolled 324 patients and was led by the Cleveland Clinic. The secondary endpoints for ASSURE included safety and tolerability of RVX-208, effects of the compound on plasma ApoA-I, HDL cholesterol, HDL-subclasses and non-HDL lipid parameters.
"Together with the study's principal investigators, we remain focused on analyzing the full data set over the coming weeks and months to determine whether continued development of RVX-208 in cardiovascular disease is warranted," said Donald McCaffrey, president and chief executive officer of Resverlogix.
