Schering-Plough platelet drug progresses to phase III

The compound, TRA-SCH 530348, is being evaluated to determine whether it has the potential to provide clinical benefit without the additional bleeding liabilities often found in current therapies. The drug is being developed for the treatment and prevention of cardiac events in patients with acute coronary syndrome and those with prior myocardial infarction or stroke, as well as in patients with existing peripheral arterial disease.

The phase III development program will include two large clinical trials to evaluate the risk reduction provided by the compound plus standard antiplatelet therapy compared to placebo plus standard antiplatelet therapy.

A phase II trial met its primary endpoint of demonstrating no increase in major and minor bleeding when this investigational compound was added to standard antiplatelet therapy among patients undergoing percutaneous coronary intervention. While not powered to establish efficacy, the study also reported a non-statistically significant 46% reduction in cardiovascular events.