Alexion Pharmaceuticals has reported results from its Phase III PRIMO-CABG2 clinical trial with pexelizumab. The results show that the drug reduced the primary endpoint, but did not meet the pre-specified threshold for statistical significance. The primary endpoint was the combined incidence of nonfatal myocardial infarction (heart attack) or death through 30 days following coronary artery bypass graft (CABG) surgery in moderate-to-high risk patients.
Pexelizumab, a terminal complement inhibitor, is a monoclonal antibody fragment that inhibits complement-mediated tissue damage. The Phase III trial included approximately 4,250 patients, and compared the safety and efficacy of pexelizumab against that of placebo in reducing heart attack and death following CABG surgery with or without concomitant valve surgery. The trial was conducted at approximately 250 U.S. and international study sites.