AtheroGenics ARISE Trial Results For AGI-1067 Full Study Fail To Show A Difference From Placebo

AtheroGenics, Inc. (NASDAQ: AGIX) today announced that its ARISE Phase III clinical study of its lead drug candidate, AGI-1067, did not show a difference from placebo in its composite primary endpoint; however, it did achieve a number of other important predefined endpoints. These endpoints included a reduction in the composite of “hard” atherosclerotic clinical endpoints, composed of cardiovascular death, myocardial infarction (heart attack) and stroke, as well as an improvement in several key diabetes parameters, including glycemic control.

A full description of the ARISE study results will be presented by the ARISE principal investigators, Jean-Claude Tardif, M.D., Director of Research; Professor of Medicine, Montreal Heart Institute; and Marc Pfeffer, M.D., Ph.D., Professor of Medicine, Harvard Medical School; Senior Physician in Cardiology at Brigham and Women’s Hospital, at the Late Breaking Clinical Trials session (Room Hall A) at the American College of Cardiology (ACC) Scientific Session in New Orleans on Tuesday, March 27 at 9:35 a.m. CDT.

While the company is disappointed that the composite primary endpoint was not met, it is encouraged by the positive results demonstrated in a number of disease states. As a result of the review of this data, the company has determined that the further development of AGI-1067 is important and the company currently intends to continue to pursue opportunities for development. The company will continue to review the data of the clinical study to prepare for discussions with the FDA to evaluate development paths forward for the drug.

A preliminary analysis of the safety data indicated that the most common adverse event was diarrhea-related and there was an observed increase in liver function tests in some patients compared to those on standard of care.