NeuroVive Pharmaceutical AB, a company focused on the treatment of acute conditions linked to mitochondria, recently announced that its investigational product CicloMulsion® did not meet the primary clinical endpoint in the phase III CIRCUS trial in patients who have experienced a particular type of heart attack called ST-segment elevation acute myocardial infarction (STEMI).
CicloMulsion is a lipid emulsion formulation of cyclosporine, an immunosuppressive drug that can inhibit cyclophilins (proteins involved in the inflammatory process). CicloMulsion was designed to prevent mitochondria dysfunction and control the several biochemical processes that can lead to secondary tissue damage. The idea is that by protecting the mitochondria function with CicloMulsion, a continued energy production is guaranteed so that a normal healing process can occur.
CicloMulsion is currently being evaluated in a randomized, multicenter, placebo-controlled phase III study (CIRCUS, NCT01502774) in 975 patients who suffered a STEMI, a severe type of myocardial infarction (heart attack) in which the coronary artery is completely blocked and a significant part of the heart muscle is unable to receive blood. This type of myocardial infarction is characterized by a specific cardiac pattern (ST segment elevation) on the electrocardiogram.
In the ongoing CIRCUS trial, patients received either one intravenous dose of CicloMulsion or a placebo drug before being treated through percutaneous coronary intervention (PCI), a procedure to reopen the coronary artery and restore blood flow to the heart. The primary clinical endpoint of the trial is a combination of three outcomes – mortality, hospitalization for heart failure and left ventricular remodeling – assessed one year after acute myocardial infarction and treatment with CicloMulsion in order to determine whether the drug is able to improve the clinical outcome in these patients. Unfortunately, this primary endpoint was not met.
“While the primary endpoint of the CIRCUS study has not been met, analysis of the full 12-month data set will provide us with more information in regard to which patients may have benefited from treatment with CicloMulsion®. These results will help define next steps in the development and commercialization of CicloMulsion®. The CIRCUS study is an independent, investigator-led study and we will continue to collaborate with the lead investigator to further evaluate the full 12-month study results as they become available,” said NeuroVive’s CEO Mikael Brönnegård in a news release. “We are confident in the NeuroVive R&D pipeline and the potential of cyclophilin inhibitors including CicloMulsion®. CicloMulsion® is one of several products and projects in clinical and preclinical stages (…) Our continuing clinical program coupled with a strong research and development pipeline will support NeuroVive’s future growth”.
The impact of these findings on CicloMulsion development will be announced in the second half of 2015. In the meantime, the CIRCUS study will continue for a further two years to assess possible long-term outcomes of treatment with CicloMulsion.