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Inspire begins phase II heart surgery trial

Inspire Pharmaceuticals has initiated a phase II clinical trial to evaluate its drug candidate, INS50589 Antiplatelet, in patients undergoing coronary artery bypass graft surgery utilizing a cardiopulmonary bypass pump.

INS50589 is a selective and reversible inhibitor of the platelet P2Y12 adenosine diphosphate receptor. The phase II clinical trial is a randomized, double-blind comparison of three doses of INS50589 to placebo by intravenous infusion in approximately 160 subjects undergoing coronary artery bypass graft (CABG) surgery.

There are multiple objectives of this dose-ranging trial, including measuring the reduction of postoperative bleeding and need for transfusions and monitoring the incidence of complications after surgery.

“From a clinical perspective, the ability to prevent platelet activation and aggregation in a controlled manner during cardiac surgery holds the potential to preserve platelet function, re-establish postoperative coagulation and reduce postoperative bleeding,” stated Dr Mark Newman, chair of the department of anesthesiology at Duke University Medical Center, and lead investigator of the trial.

“It is exciting to study INS50589 in patients undergoing CABG surgery since the compound demonstrated in a recent phase I trial the ability to modulate platelet function by binding to the P2Y12 receptor and blocking platelet aggregation,” he continued.

Inspire expects to have results from the trial in the first half of 2007.