ASSURE Phase 2b IVUS

RVX-208 is the first in a new class of ApoA-I production small molecules to enter a Phase 2b intravascular ultrasound (IVUS) clinical trial. ASSURE is a 26-week, multi-center, double-blind, randomized, parallel group, placebo-controlled clinical trial that will assess coronary atherosclerotic plaque changes in response to our lead drug RVX-208 using IVUS technology. 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 twice daily of RVX-208. An IVUS measurement will be taken prior to the first dose of RVX-208 and this will be repeated after 26 weeks of treatment. The primary trial 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.

SUSTAIN Phase 2b

Also underway is SUSTAIN a Phase 2b clinical trial comprised of 176 subjects, which as of November 2011 is fully enrolled. The Cleveland Clinic leads this trial in which all subjects have established atherosclerotic cardiovascular disease (CVD) and low high-density cholesterol (HDL-C). In SUSTAIN, all subjects will receive standard of care therapy that includes up to 40 mg atorvastatin (Lipitor) or 20 mg rosuvastatin (Crestor). Despite the standard of care therapy in the SUSTAIN population, the risk of recurrent CVD events remains exceedingly high. Thus this patient population presents an ideal opportunity to test the effects of placebo vs. RVX-208 (200 mg/day) an orally active small molecule that raises ApoA-I production and thereby increases HDL-C. SUSTAIN is a 24-week, multi-center, double-blind, randomized, parallel group, placebo controlled clinical trial to assess lipid trends and safety of RVX-208. Additionally, other biomarkers of reverse cholesterol transport (RCT) will be examined. The primary endpoint of SUSTAIN is the change in HDL-C from baseline after receiving RVX-208 for 24 weeks vs. placebo. Secondary endpoints include change in ApoA-I, LDL-C, non-HDL-C, apoB, TG and HDL subclasses

More About RVX-208

RVX-208 the Company’s lead drug, is a novel small molecule therapeutic that facilitates endogenous ApoA-I production. It 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 preventing and reversing atherosclerosis.