Resverlogix Corp. has announced that it has completed dosing in ASSURE, a Phase 2b clinical trial evaluating RVX-208, Resverlogix's first-in-class orally active BET-protein inhibitor, using intra-vascular ultrasound (IVUS) in high-risk cardiovascular patients with low HDL and ApoA-I (n=324).
These target patients have significant residual risk in major adverse coronary events (MACE) such as heart attack, unstable angina, stroke, revascularization and death, despite standard of care therapy such as statins.
The main underlying cause of the residual risk in these patients is atherosclerosis. ASSURE is designed to evaluate the ability of RVX-208 to regress atherosclerotic disease.
"Atherosclerosis regression represents a new paradigm in the treatment of high-risk cardiovascular disease patients," said Donald McCaffrey, president and chief executive officer of Resverlogix. "The completion of the ASSURE trial is a major development milestone for the company. RVX-208 is the first small molecule BET inhibitor that raises the production of ApoA-I to be tested in a landmark IVUS trial."
ASSURE is a 26-week, multi-center, double-blind, randomized, parallel group, placebo-controlled trial led by the Cleveland Clinic.
To assess atherosclerosis regression in ASSURE, all subjects were examined using IVUS. The primary endpoint in ASSURE is to detect a change in percent atheroma volume as determined by IVUS at baseline vs. 26 weeks of treatment.
The use of IVUS technology will provide details regarding plaque composition and stability, which is important because both are elements leading to acute coronary syndrome.
Secondary endpoints for ASSURE include safety and tolerability of RVX-208, effects of the compound on plasma ApoA-I, HDL-C, HDL-subclasses and non-HDL lipid parameters such as the CRP inflammation marker. Top line data is expected mid-2013.