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AtheroGenics Heart Drug Fails to Meet Phase III Endpoint

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By: Tim Wright

Editor-in-Chief, Contract Pharma

AtheroGenics, Inc.’s AGI-1067, which is being developed in partnership with AstraZeneca, did not meet its primary endpoint in a Phase III trial. AGI-1067 is aimed at reducing the buildup of plaque inside arteries by addressing the inflammation behind heart disease.

The study compared the effect of AGI-1067 to placebo in more than 6,000 patients with heart disease on the time to first incidence of a composite of major adverse cardiovascular events such as resuscitated cardiac arrest, heart attacks, stroke, need for coronary revascularization and hospitalization for unstable angina.

AtheroGenics will continue to develop the drug based on positive results in reducing events such as cardiovascular death, heart attack and stroke, as well as improving several key diabetes parameters.

In a company statement, AtheroGenics will review the data to prepare for discussion with the FDA on how to proceed. AstraZeneca has 45 days to decide whether to continue the collaboration.

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