The drug did not show a difference from placebo in the study, although the company said that it did achieve a reduction in the composite of “hard” atherosclerotic clinical endpoints, composed of cardiovascular death, myocardial infarction (heart attack) and stroke. The drug also demonstrated an improvement in several key diabetes parameters, including glycemic control.
US-based AtheroGenics said: “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.”
The company also said that it intends to continue with the further development of AGI-1067 and 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.
AtheroGenics and AstraZeneca have a worldwide collaboration covering the development and commercialization of AGI-1067. After completion of the final analysis, under the terms of the license and collaboration agreement, AstraZeneca has a 45-day period in which to decide whether or not to continue with the collaboration.