Resverlogix Corp. has announced that dosing in SUSTAIN, a Phase 2b clinical trial to assess lipid trends and safety of RVX-208, has been completed on schedule.
All patients in the Cleveland Clinic led trial had significant cardiovascular disease (CVD) risks.
In SUSTAIN, a 24-week, multi-centered, double-blind, randomized, parallel group, placebo controlled trial, all subjects received standard of care therapy including up to 40 mg atorvastatin (Lipitor) or 20 mg rosuvastatin (Crestor).
As recently stated, RVX-208 is the first known BET Bromodomain inhibitor to be studied in humans. It is an orally active small molecule that raises ApoA-I production leading to enhanced reverse cholesterol transport (RCT).
SUSTAIN trial subjects received either RVX-208 (200 mg/day) or placebo for 24 weeks for the purposes of studying a panel of lipid parameters versus baseline.
SUSTAIN is an important component of an expanded clinical program that includes a parallel Phase 2b clinical trial, ASSURE.
The ASSURE trial will utilize intravascular ultrasound (IVUS) to study the important atherosclerotic plaque regressing aspects of RCT.
The unique mechanism by which RVX-208 can potentially regress atherosclerotic plaque distinguishes it from all other known drug classes or small molecule candidates in clinical development.
Resverlogix expects to report top line data for SUSTAIN in Q3 2012 and for ASSURE in Q1 2013.
"We have completed dosing in the SUSTAIN trial, right on schedule," stated Donald McCaffrey, president and chief executive officer of Resverlogix.
McCaffrey continued, "Data from this trial will be used to assess the safety and efficacy of RVX-208 in a high-risk population with CVD. This population provides an ideal opportunity to test the effects of RVX-208. We are particularly interested in confirming the safety of RVX-208 in the extended dosing time frame from three to six months."
Allan Gordon, M.D., Ph.D. and senior vice president of clinical development at Resverlogix, added, "the SUSTAIN trial extends the duration of clinical exposure to RVX-208 by 3 months. Not only will this data provide us with important insights into the safety and efficacy of RVX-208, we also expect important new information for the future development of RVX-208."