Resverlogix completes ASSURE clinical trial

Resverlogix has completed its ASSURE clinical trial, which evaluates the first-in-class orally active BET-protein inhibitor RVX-208.

The drug is being tested using intra-vascular ultrasound in high risk cardiovascular patients with low HDL and ApoA-1 (n=324), with the target patients boasting substantial residual risk in major adverse coronary events such as heart attacks and unstable angina.

Atherosclerosis has been noted as the main underlying cause of the residual risk in the patients, and ASSURE is designed to review the ability of RVX-208 to regress atheroscelrotic disease.

ASSURE is being carried out by the Cleveland Clinic and the primary endpoint in it is to detect a change in percent atheroma volume, which will be judged by looking at IVUS at baseline and comparing it with 26 weeks of treatment.

Secondary endpoints for ASSURE include safety and tolerability of RVX-208, the effects of the compound on plasma ApoA-1, HDL-C, HDL-subclasses and non-HDL liquid parameters including the CRP inflammation marker, with top line data expected in the middle of 2013.

Donald McCaffrey, president and chief executive officer of Resverlogix, said: “Atherosclerosis regression represents a new paradigm in the treatment of high-risk cardiovascular disease patients.

“The completion of the ASSURE trial is a major development milestone for the company. RVX-208 is the first small molecule BET inhibitor that raises the production of ApoA-I to be tested in a landmark IVUS trial.”

RVX-208 is the first-in-class small molecule that inhibits BET bromodomains, with the drug working by removing atherosclerotic plaque through reverse cholesterol transport.

RVX-208 increases the production of ApoA-1, which is the key building block of functional high-density lipoprotein particles.

These particles are flat and empty and are capable of effectively removing plaque and stabilising or reversing atheroscelrotic disease.

Resverlogix carries out work on a number of clinical stage cardiovascular solutions and boasts an epigenetic platform technology to modulate protein production.