The topline result will provide baseline information on whether the primary endpoint has been met or not. This result will not contain specific data concerning the level of significance for neither the combined composite endpoint itself nor for each individual element of the composite, which will be revealed in the subsequent detailed analysis. The primary endpoint is a composite of three separate outcomes: mortality, hospitalizations for heart failure and left-ventricular remodeling.
The impact of these results on the future development of CicloMulsion® will be communicated in the second half of 2015.
About CicloMulsion®
NeuroVive’s drug candidate CicloMulsion®, a lipid emulsion formulation of cyclosporine, is the first cyclophilin inhibitor in development for the treatment of reperfusion injury. It is designed to prevent mitochondrial death in damaged cells and limit the numerous biochemical processes that lead to secondary tissue damage following heart attack. By protecting the cells’ mitochondria, CicloMulsion® may safeguard continued energy production and ensure that the damaged cells’ normal regenerative mechanisms are able to carry out repairs and maintain cell functionality. CicloMulsion®’s potential for treatment in connection with myocardial infarction is currently being evaluated in a clinical phase III study. CicloMulsion® is also being evaluated in a phase II study for the prevention of renal injury during major heart surgery with Skåne University Hospital in Lund, Sweden. CicloMulsion® is an investigational product and has not been approved by regulatory agencies for the treatment of any medical condition.
About the ongoing phase III study on CicloMulsion®
The ongoing European phase III study on CicloMulsion® (the CIRCUS study) is being conducted in France, Belgium and Spain. The study evaluates CicloMulsion® for the treatment of reperfusion injury in patients that have undergone percutaneous coronary intervention (PCI) following myocardial infarct. The researcher responsible for the study is Professor Michel Ovize at Hospices Civils de Lyon (HCL) in Lyon, France. The study is a double-blind, placebo-controlled study, and the final of a total 975 patients included in the study was enrolled in February 2014. The top-line result (met or did not meet primary endpoint) based on the 12-month follow-up of all patients is expected to be announced in the second quarter of 2015, and the full results of the 12-month data are expected in the third quarter of 2015. The study will also evaluate outcomes at 36 months.
About NeuroVive
NeuroVive Pharmaceutical AB (publ), the mitochondrial medicine company, is developing a portfolio of products to treat acute cardiovascular and neurological conditions through mitochondrial protection. NeuroVive’s drug candidate CicloMulsion® is being evaluated in an ongoing phase III study, CIRCUS, in myocardial infarction and a phase II study, CiPRICS, in acute kidney injury. The drug candidate NeuroSTAT® is currently being evaluated in a phase II study in traumatic brain injury. NeuroVive’s research programs also include development of drug substances against brain injury in stroke patients and for cellular protection and energy regulation in mitochondrial disease. NeuroVive’s shares are listed on NASDAQ OMX, Stockholm, Sweden.
For Investor Relations and media questions, please contact:
Ingmar Rentzhog, Laika Consulting, Tel: +46 (0)46 275 62 21 or ir@neurovive.se
It is also possible to arrange an interview with NeuroVive’s CEO Mikael Brönnegård or COO Jan Nilsson at the above contact.
NeuroVive Pharmaceutical AB (publ)
Medicon Village, SE-223 81 Lund, Sweden
Tel: +46 (0)46 275 62 20 (switchboard), Fax: +46 (0)46 888 83 48
info@neurovive.se, www.neurovive.se
NeuroVive Pharmaceutical AB (publ) is required to publish the information in this news release under The Swedish Securities Market Act. The information was submitted for publication on 25 May 2015, at 8:30 a.m. CET.