The results show that the drug reduced the primary endpoint of 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. However, the results did not meet the pre-specified threshold for statistical significance.
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 US and international study sites, and was sponsored jointly by Alexion and Procter & Gamble Pharmaceuticals.
“We look forward to completing an analysis of the data and obtaining a more in-depth understanding of these results,” said Dr Leonard Bell, CEO of Alexion.
Alexion is assessing the implications of the results on its second international pivotal phase III study of pexelizumab, which is investigating the benefits of using pexelizumab in patients experiencing a heart attack who are treated with primary percutaneous coronary intervention (PCI), or angioplasty.