NeuroVive Pharmaceutical AB (publ), the mitochondrial medicine company, is currently conducting a Phase III clinical study (“CIRCUS”) with its lead candidate CicloMulsion® in patients with ST-segment elevation acute myocardial infarction (STEMI). Topline results are expected in this quarter, which is sooner than expected, and will determine the success of meeting the primary endpoint of the study.
CicloMulsion is designed to stop mitochondrial damage in cells following a heart attack. It is a lipid emulsion containing cyclosporine and is the first cyclophilin inhibitor tested in patients at risk for reperfusion injury. By limiting biochemical processes that may lead to reperfusion injury, CicloMulsion preserves cells’ mitochondria and energy producing capabilities.
There are currently two Phase III clinical trials testing CicloMulsion. One is evaluating the therapy in myocardial infarction, and the other is evaluating the therapy in preventing renal injury during major heart surgery. The first trial, CIRCUS, is ongoing at institutions in France, Belgium, and Spain. Professor Michel Ovize at Hospices Civils de Lyon (HCL) in Lyon, France, is the principal investigator for the study.
Nearly 1,000 patients are enrolled in the study, which was fully enrolled in February 2014. Final results are expected in the third quarter of 2015, but topline results are expected soon. Topline results will indicate whether or not the primary endpoint was met following 12 months of treatment with CicloMulsion or a placebo. Additional results will be released after patients are treated for a total of 36 months.
The primary endpoint considers three separate outcomes. Mortality, hospitalizations for heart failure, and left-ventricular remodeling are being evaluated for each patient. Although topline results will not indicate significance between treatment groups, full results in the future will. These results will indicate whether or not the mitochondrial-preserving therapy CicloMulsion is effective in preventing further damage in myocardial infarction.