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news.Phase 1b/2a study testing RVX-208 for 28 days in three different doses increase plasma ApoA-1
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Resverlogix has released several quarterly updates for RVX-208, as apotential treatment of atherosclerosis and cardiovascular disease. The company claims that the phase 1b/2a study testing RVX-208 for 28 days in three different doses has met its primary endpoint of increasing plasma ApoA-I significantly.
The company said that quality controls are still ongoing as part of regular good clinical practice, thus the compilation of the full data report are expected within the second half of 2009.
Resverlogix claims that the plasma ApoA-I increase is significant during treatment and at the lowest dose, while continued increases follow a dose-response and time-response pattern. This data is building on similar results from non-human primate studies and a previous 7-day study in humans last year that also showed significant ApoA-I increases. The safety data has not yet been compiled according to patients who received active or placebo treatment. From the safety blood analysis and conduct of the study it can be concluded that RVX-208 is safe and tolerable at doses efficient in increasing plasma ApoA-I concentrations.
It is reported that since RVX-208 increases ApoA-I by production, the phase 1b/2a trial also examined early markers for ApoA-I production and reverse cholesterol transport such as pre-beta-HDL and Alpha1-HDL. Approximately half of the subjects had low levels of HDL cholesterol.
Donald McCaffrey, president and CEO of Resverlogix, said: Showing in the phase 1b/2a trial that we met the primary endpoint of increasing plasma ApoA-I in a safe and tolerable way is a huge milestone for Resverlogix. There is an enormous unmet medical need in treating atherosclerosis and cardiovascular disease and the ApoA-I increases achieved by RVX-208 may just do that. We expect to update shareholders with further details of these activities later this year.
In addition to the phase 1b/2a trial, Resverlogix has also completed two arms of a phase 1 BE (bio-equivalency) study for RVX-208 with the final arm being scheduled for completion in the end of the third quarter.