Resverlogix Corp. (“Resverlogix”) (TSX:RVX) announces today that study sites for the Phase 2b ASSURE clinical trial have now been activated. This step opens the door for enrollment of patients in ASSURE (ApoA-l Synthesis Stimulation in Acute Coronary Syndrome), a 26-week, multi-center, double-blind, randomized, parallel group, placebo-controlled clinical trial that will assess coronary atherosclerotic plaque changes in response to the Company’s lead compound RVX-208 using intravascular ultrasound (IVUS). ASSURE will examine the early effects of RVX-208 induced ApoA-I production on atherosclerotic plaque regression in the setting of patients with coronary artery disease who have a low level of high-density lipoprotein cholesterol (HDL-C). A total of 310 patients are expected to participate in ASSURE of which 77 will receive placebo and 233 will be given 100 mg given twice daily of RVX-208.
The primary endpoint will be IVUS measurement of a change in percent atheroma volume from baseline to 26 weeks. Secondary objectives for ASSURE are; (i) safety and tolerability of RVX-208 as reflected by adverse events, and (ii) effects of RVX-208 on HDL and non-HDL lipid parameters. Enrollment for ASSURE is expected to be completed by the end of the year. The ASSURE study chair is Dr. Steven Nissen, MD, Chairman of the Cleveland Clinic Department of Cardiovascular Medicine. The principal investigator for the trial is Dr. Stephen Nicholls, Medical Director of Intravascular Ultrasound at Cleveland Clinic.
“The ASSURE protocol arose from valuable knowledge gained in our Phase 2 ASSERT trial. The ASSERT data clearly separates RVX-208 from its competitors by affecting three key biomarkers in reverse cholesterol transport (RCT). In ASSERT, subjects given RVX-208 had; (i) a dose dependent and sustained increase in ApoA-l levels, (ii) a significant rise in HDL-C, especially alpha-1 particles or functional HDL, and (iii) a highly statistically significant increase in large HDL particles. These pronounced changes in the HDL profile arises from the initial RVX-208 induced increase in ApoA-I production and these changes in HDL point to enhanced RCT which in turn gives rise to the potential for atherosclerotic plaque regression,” stated Dr. Jan Johansson, Resverlogix’s Senior Vice President of Medical Affairs. “Furthermore, we were encouraged by the dose-response relationship for lowering of hyper sensitive C-reactive protein (hs-CRP), also suggesting a beneficial effect on the artery wall,” Dr. Johansson added.
“We are pleased to announce the initiation of the Phase 2b ASSURE trial; the foundation of which is based on critical knowledge from ASSERT. In particular, the unique pathway by which RVX-208 raises ‘functional’ HDL in leading to atherosclerotic plaque regression, gives our lead compound a potential strategic advantage over other HDL therapies,” stated Donald J. McCaffrey, President and Chief Executive Officer of Resverlogix.
About RVX-208
RVX-208 is a novel, orally active small molecule that stimulates endogenous ApoA-I production to trigger the synthesis of HDL. ApoA-I is the major protein component of HDL. The use of this approach will enhance the functionality of HDL. The main role of these particles is to act as the body’s natural defense system against atherosclerosis by mediating a normal physiologic process called reverse cholesterol transport (RCT). This pathway enables cholesterol, including that within atherosclerotic plaques of vessel walls, to be transported to the liver for further processing and elimination from the body. Enhanced RCT clearance of cholesterol from vessel walls should reduce or prevent atherosclerosis. The ability of RVX-208 to increase ApoA-I production and thereby augment RCT makes it highly differentiated from all other HDL therapies. Thus RVX-208 is positioned to be one of the most promising drugs in development for the treatment of atherosclerosis.
About Resverlogix Corp.
Resverlogix Corp. is a leading biotechnology company engaged in the development of novel therapies for important global medical markets with significant unmet medical needs. The NexVas™ Plaque Regression program is the Company’s primary focus which is to develop novel small molecules that enhance ApoA-I production. These vital therapies are focused to address the burden of atherosclerosis and other important diseases such as Acute Coronary Syndrome, Alzheimer’s disease, Peripheral Artery Disease and Autoimmune diseases. Resverlogix Corp.'s common shares trade on the Toronto Stock Exchange (TSX:RVX). For further information please visit www.resverlogix.com.
