S-P's oral antiplatelet drug to enter Ph III trials

New Jersey, USA-based drug major Schering-Plough says that it plans to initiate two global Phase III studies of its developmental antiplatelet agent, the thrombin receptor antagonist, SCH 530348. The firm said that the drug would be examined both for its ability to reduce the occurrence of major cardiovascular events, and for the level of treatment-related bleeding with which it is associated.

S-P explained that the Phase III development program will include two large-scale clinical trials that will examine the risk reduction provided when SCH530348 is combined with standard antiplatelet therapy, including aspirin and clopidogrel, versus standard therapy plus placebo. The firm also said that the trials would seek to enroll two key patient groups, those suffering from acute coronary syndrome as well as those who have suffered a prior myocardial infarction, in whom the compound will be studied as a secondary preventative therapy. The primary endpoint of both trials will be a composite measure of the cardiovascular death rate, the occurrence of MI and stroke.

S-P said that the results of a previously-completed Phase II trial, presented at the scientific sessions of the American College of Cardiology meeting in New Orleans, revealed that the drug had not increased the occurrence of major or minor bleeding events when added to standard antiplatelet therapy in patients undergoing percutaneous coronary intervention. The firm added that, while the program had not been designed to measure the agent's therapeutic efficacy, treatment did result in a non-statistically significant 46% reduction in cardiovascular events at the highest dose tested. Eugene Braunwald, professor of medicine at Harvard Medical School, and chairman of the Phase III study group, commented that "one of the treatment goals is to identify a medication that can reduce the risk [of a potentially life threatening cardiovascular events] without the high incidence of bleeding that frequently accompanies currently available therapies."