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Phase 3 Trial of AGI-1067 Fails to Meet Primary Endpoint
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.
The ARISE (Aggressive Reduction of Inflammation Stops Events) trial is a Phase III, double-blind, placebo-controlled trial in over 6100 patients with a recent acute coronary syndrome (ACS). The trial was conducted in 259 cardiac centers in the United States, United Kingdom, Canada and South Africa. The primary endpoint in the ARISE study was to compare the effect of AGI-1067 to placebo on the time to first incidence of a composite of major adverse cardiovascular events (MACE), specifically cardiovascular death, resuscitated cardiac arrest, myocardial infarction, stroke, need for coronary revascularization and admission to hospital for unstable angina.