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ARTICLE | Clinical News

RVX-208: Additional Phase II data

September 5, 2011 7:00 AM UTC

Additional data from the double-blind, U.S. Phase II ASSERT trial in 299 patients showed that 100-300 mg daily RVX-208 enhanced biomarkers of reverse cholesterol transport and a reduction in inflammatory biomarkers. Specifically, RVX-208 plus standard of standard of care (SOC) was associated with dose-dependent increases in APOA1 levels of 0.1-5.6%, HDL-C of 3.2-8.3%, large HDL particles of 11.1-21.1% and large APOA1 particles of 3.7-8.8%. There was also a non-significant dose-dependent reduction in C-reactive protein (CRP) levels by 13-22%. Patients receiving RVX-208 demonstrated a significant inverse relationship between HDL-C changes and CRP levels (p=0.004).

Additionally, increases in HDL-C were significantly correlated with increased total HDL particles (p<0.0001), large HDL particles (p<0.0001), small HDL particles (p=0.0002), prebeta-1 HDL particles (p=0.009) and APOA1 particles (p<0.0001). Patients from the quartile with the greatest increase in HDL-C had significantly greater increases in HDL particle concentration (10.1% vs. -3.1%, p<0.0001) and size (2.3% vs. 0%, p<0.001), large HDL particles (46.9% vs. -9.1%, p<0.001), prebeta-1 HDL particles (6.6% vs. -5.1%, p=0.04) and APOA1 particles (29.5% vs. -20.9%, p<0.001) vs. patients in the lowest quartile. Data were presented at the European Society of Cardiology meeting in Paris. ...