The phase II proof-of-concept clinical trial was a randomized, double-blind comparison of three doses of INS50589 to placebo by intravenous infusion and was targeted to enroll approximately 160 subjects undergoing coronary artery bypass graft (CABG) surgery.
However, after a planned interim review of data from 27 patients enrolled and treated in the trial, the independent data monitoring committee (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 FDA 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,” said Donald Kellerman, Inspire’s senior vice president of development. “However, based on our current information, it is likely that we will reallocate time and capital to key programs in our core therapeutic areas of ophthalmology and respiratory/allergy.”