Medicure Inc, a cardiovascular focused biopharmaceutical company, said an analysis of the data from its pivotal phase III MEND-CABG II clinical trial did not meet the primary endpoint. The trial was designed to evaluate the effect of Medicure's lead product MC-1, versus placebo, on the incidence of cardiovascular death or nonfatal myocardial infarction up to and including 30 days following coronary artery bypass graft (CABG) surgery.
Based on the results, the company does not plan on submitting an application for MC-1 marketing approval to the US Food and Drug Administration for the CABG indication at this time.
The pivotal phase III MEND-CABG II trial was a double-blind, randomized, placebo-controlled clinical trial that enrolled over 3,000 patients undergoing CABG surgery at more than 130 cardiac surgical centres throughout North America and Europe.
Study patients were randomised to receive placebo or MC-1 250 mg prior to surgery and for 30 days post operatively (POD 30). The primary efficacy endpoint of MEND-CABG II was the incidence of cardiovascular death or non-fatal myocardial infarction up to and including POD 30. Study patients were followed for 60 days after treatment (90 days post operatively) for additional safety and efficacy analysis. The study was initiated in November 2006 and is subject to a Special Protocol Assessment with the FDA.
Medicure conducted the MEND-CABG II study in conjunction with Duke Clinical Research Institute (DCRI) and Montreal Heart Institute (MHI). Principal investigators for the study are Dr. Robert Harrington, Director of the DCRI, and Dr. Michel Carrier, Director of Cardiovascular Surgery Programme at MHI.
CABG is performed to improve blood flow to the heart by re-routing blood around blocked arteries. CABG surgery is one of the 10 most frequently performed procedures in North America. More than 400,000 CABG procedures are performed each year in the US alone. Coronary artery disease incidence is increasing dramatically worldwide, creating a major demand for products that make CABG surgery safer for patients.