Resverlogix Corp. (Resverlogix) announced that the company has completed its chronic repeated-dose toxicology studies on its lead compound, RVX-208, indicated for the reduction and prevention of atherosclerosis. These chronic toxicology studies support the initiation of its longer duration, phase II b, clinical trial ASSURE. As a first-in-class compound, RVX-208 underwent six and twelve month testing in rodents and non-rodents, respectively, and the analysis, results and reporting of these studies to the appropriate regulatory authorities, have been completed.
With the safety studies complete, RVX-208 can now advance into trials of more than three months duration. The phase II b ASSURE trial, in which Intra Vascular Ultra Sound (IVUS) technology will be used to determine coronary arterial plaque regression, will have a treatment duration of six months. The IVUS measurement will be used as the trial's primary endpoint.
Results from the recently completed ASSERT trial strongly demonstrate that RVX-208 is efficacious in elevating new production of ApoA-1, the key protein in 'good cholesterol', HDL cholesterol and HDL Alpha1 sub particles. None of these reverse cholesterol transport biomarkers appear to have reached their plateaus at the completion of that 12 week trial. As a result, Resverlogix was required by the FDA rules to complete the safety studies in order to progress to a six month human clinical study.
Resverlogix has identified more than 60 clinical sites in eight countries that will participate in the ASSURE trial study. The Cleveland Clinic will serve as the trial co-manager and coordinate all data management and readouts of the primary endpoint. Countries with secured trial sites are located in both Europe and South America. With the completion of these chronic repeated-dose toxicology studies, Resverlogix has commenced the required national approval filings. Upon completion of regulatory filings in each specific country, Resverlogix will then commence enrollment and dosing procedures.
“We are pleased to have completed and filed the data associated with the repeated-dose toxicology studies and that the trial is progressing according to timelines that we had previously discussed,” said Donald J McCaffrey, president and chief executive officer, Resverlogix.
The ASSURE trial is a placebo-controlled, double-blind intervention trial designed by Resverlogix in conjunction with the Cleveland Clinic and the Clinical Steering Committee, consisting of Drs Steve Nissen, John Kastelein, Christie Ballantyne, Phil Barter, and principal investigator Dr Stephen Nicholls. The trial patient population will be selected from patients referred for coronary angiography who meet selected angiographic criteria. Approximately 310 patients will participate, of which 77 will receive placebo and 233 will receive RVX-208 treatment.
RVX-208, a novel small molecule therapeutic that facilitates endogenous ApoA-1 production, is positioned to be one of the most promising emerging drugs in the treatment of atherosclerosis. To the company's knowledge RVX-208 is the only novel small molecule that is specifically designed to increase ApoA-I production and thereby raise HDL levels thus enhancing HDL functionality to augment Reverse Cholesterol Transport (RCT). RCT is a pathway by which accumulated cholesterol is transported from the arterial wall to the liver for excretion, thus reducing or preventing atherosclerosis.
Resverlogix Corp. is a leading biotechnology company engaged in the development of novel therapies for important global medical markets with significant unmet medical needs.Such vital therapies are focused to address the burden of atherosclerosis and other important diseases such as Acute Coronary Syndrome, Diabetes, Alzheimer's disease, Peripheral Artery Disease and other vascular disorders.