INSPIRE HALTS TRIAL ON DMC RECOMMENDATION

Inspire Pharmaceuticals has terminated its Phase II trial of INS50589 anti-platelet based on the unanimous recommendation of its independent data monitoring committee (DMC), following a planned interim safety analysis.

INS50589 is a selective and reversible inhibitor of the platelet P2Y12 adenosine diphosphate receptor. The Phase II proof-of-concept clinical trial was a randomized, double-blind comparison of three doses of INS50589 (0.2, 0.5 and 1 mg/kg/hour) to placebo by intravenous infusion and was targeted to enroll approximately 160 subjects undergoing coronary artery bypass graft surgery. After the planned interim review of data from 27 patients enrolled and treated in the trial, the DMC recommended that Inspire terminate the trial at all dose levels. Although there were no deaths reported in the trial, the DMC observed a range of bleeding complications.

"We have notified the U.S. Food and Drug Administration and are communicating with investigators about this action. Once we gain access to the data, we plan to conduct a thorough internal analysis to better understand the findings of the DMC," Donald Kellerman, Inspire's senior vice president, said.