Resverlogix Corp. (“Resverlogix”) announces its top line results of the ASSERT Phase 2
clinical trial which will be highlighted at the prestigious American Heart Association
Scientific Sessions 2010 Late Breaking Clinical Trial session, by principal investigator
Dr. Stephen Nicholls of the Cleveland Clinic. The top line ASSERT trial data was
designed to answer questions about how to best proceed with future trial designs for
Resverlogix' lead oral small molecule drug RVX-208.
The ASSERT trial data demonstrated that the three key biomarkers in the reverse
cholesterol transport (RCT) process showed dose dependant and consistent
improvement. The trial showed 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
are important as they take place later in the RCT chain of events and strongly indicate
plaque regression potential.
An additional presentation at the AHA meeting was given by Dr. Norman Wong, Chief
Scientific Officer of Resverlogix, containing new data detailing the effects of RVX-208 in
vivo. The presentation was titled "RVX-208: An Orally Administrated Small Molecule
Reduces Atherosclerosis in ApoE Null Mouse and Raises ApoA-I/HDL in Humans". In
the ApoE null mice model of atherosclerosis, the oral administration of RVX-208 reduced
aortic plaques in two separate models. The presented model showed plaque reductions of up to 41%.