Resverlogix begins Phase 2 atherosclerosis trial

Resverlogix (TSX:RVX) has begun dosing patients two months ahead of schedule in a Phase 2 clinical trial to examine its RVX-208 therapy as a treatment for atherosclerosis in patients with stable coronary artery disease (CAD).

Led by the Cleveland Clinic, the double-blind, placebo-controlled Assert study will administer RVX-208 to about 280 patients with stable CAD for 13 weeks.  A total of 40 investigator sites across the U.S. will be participating in the study.

“The initiation of the Assert trial is another important milestone that Resverlogix has achieved this year,” CEO Donald McCaffrey said in a statement.

Statins are the current standard of care in CAD, but they only stop atherosclerosis from progressing and, in almost all cases, are unable to remove it.  If RVX-208 can achieve this goal it would be an “important step toward the reduction of disease risk and lower health system costs,” he added.

The primary objective of this study is to determine if RVX-208 will produce an increase in plasma ApoA-l levels compared with placebo group after three months of dosing.  The secondary objectives are to examine the safety and tolerability of RVX-208, to compare the dose and time response relationships for ApoA-l over time, and to examine reverse cholesterol makers such as Alpha 1 HDL.

The trial is one of two parallel studies: in this study, the focus is on stable CAD patients, while the second trial will be focused on unstable acute coronary syndrome and will include the use of intravascular ultrasound.