Schering-Plough announces start of phase III antiplatelet study

Schering-Plough has announced plans for the start of two worldwide phase III clinical studies investigating the use of SCH 530348 – an orally-administered novel selective antiplatelet therapy.

The compound is being evaluated as a treatment and preventative measure against cardiac events in acute coronary syndrome patients, those with existing arterial disease and those with previous history of stroke or myocardial infarction.

Studies will evaluate the efficacy of the compound for these patients while also assessing its improvement, if any, on the bleeding liabilities found in other treatments.

The clinical trials will evaluate risk reduction provided from standard antiplatelet therapy plus SCH 530348 compared with patients receiving traditional antiplatelet therapy plus placebo in two separate patient groups.

SCH 530348 is a thrombin receptor agonist (TRA) that obstructs thrombin – a stimulus of platelet activation that drives clotting in the body.

Thomas P Koestler, executive vice-president and president of Schering-Plough Research Institute, said: “The advance of our novel selective antiplatelet TRA to phase III represents a significant milestone for a compound.”

Last month, Schering-Plough reported that SCH 530348 had met its primary endpoint in a phase III clinical trial of showing no increase in either minor or major bleeding when measured by the Timi bleeding scale.