Data was also presented for Resverlogix's Phase 1a safety and pharmacokinetic human study which was comprised of a total of 80 subjects. RVX-208 was found to be well tolerated and had good oral absorption meeting the objectives of safety and pharmacokinetics.
In the multiple ascending dose arms, 24 participants were randomly assigned to 3 cohorts of 8 healthy volunteers (6 active and 2 placebo), and received oral administration of RVX-208 at 2, 3 and 8 mg/kg/day or placebo for 7 days. ApoA-I, HDL-C, HDL particle size distribution and ABCA1-dependent cholesterol efflux were assessed on day 1 (pre-dose) and day 7. Following administration for 7 days, treatment with RVX-208 increased the change for ApoA-I by 11% (P=0.03) in treated subjects compared with placebo. Interestingly, the corresponding prebeta-HDL change was 42% (P=0.007) in the actively treated group compared to control. Furthermore, sera from subjects were assessed for ABCA1 mediated cholesterol efflux as a predictive marker for reverse cholesterol transport. Again, ABCA1-dependent cholesterol efflux change increased by 10% (P=0.03) and was found to correlate with increased prebeta-HDL. Taken together these data demonstrate the ability of RVX-208 to generate prebeta-HDL, improve HDL functionality, which clearly differentiates RVX-208 from other HDL therapies, and making it the first of a new drug class.
RVX-208, a novel small molecule therapeutic that facilitates endogenous
ApoA-I production, is positioned to be one of the most promising emerging
|SOURCE Resverlogix Corp.|
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