Phase 2 study of RVX-208 for the treatment of advanced coronary disease

Resverlogix announced results from its Phase 2 trial of RVX-208 for the treatment of advanced coronary disease. This trial, known as the ASSERT trial, demonstrated that the three key biomarkers in the reverse cholesterol transport (RCT) process showed dose dependant and consistent improvement. The three biomarkers were dose dependent increases in ApoA-l, statistically significant increases in HDL cholesterol including alpha1 particles or functional HDL, and highly statistically significant increases in large HDL particles. RCT is a pathway by which accumulated cholesterol is transported from the arterial wall to the liver for excretion, thus reducing and/or preventing atherosclerosis.

In the high dose, ApoA-I achieved a 5.6% increase with a statistical value of p=0.06. The overall ApoA-I biomarker showed a dose trending statistical significance of p=0.035. Data presented also showed that the ApoA-I and other HDL particles continued to be increasing at the end of the 12 week study. Both the 8.3% HDL cholesterol increase and the 21.1% large particle HDL increase were highly statistically significant, p<0.01 and p<0.001 respectively. These pronounced HDL related increases via ApoA-I production take place later in the RCT chain of events and strongly indicate plaque regression potential.

RVX-208 is a small molecule designed to increase levels of ApoA-I, the apolipoprotein component of HDL cholesterol. 

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