BioCentury
ARTICLE | Clinical News

RVX-208: Phase IIb data

July 1, 2013 7:00 AM UTC

Top-line data from the double-blind, placebo-controlled, international Phase IIb ASSURE trial in 324 high-risk CAD patients with low levels of HDL-C showed that twice-daily 100 mg oral RVX-208 missed the primary endpoint of a 0.6% reduction in atheroma volume from baseline to week 26 as measured by IVUS. Specifically, RVX-208 led to a 0.4% reduction in atheroma volume from baseline (p=0.08). RVX-208 did meet the secondary endpoints of regression of total atheroma volume and increases in APOA1 and HDL-C. Resverlogix plans to analyze the full data set "over the coming weeks and months" to determine whether it will continue development of RVX-208 in cardiovascular disease. The company also said that unexpected "strong" placebo results will need to be further explored, but declined to disclose details. The trial was led by the Cleveland Clinic. ...