Bellerophon Therapeutics, a clinical stage biotherapeutics company, announced that it has completed enrollment of its PRESERVATION I clinical trial of Bioabsorbable Cardiac Matrix (BCM), an investigational implantable medical device being studied for the prevention of congestive heart failure following an acute myocardial infarction (AMI), commonly known as a heart attack.
The treatment procedure has been completed in 303 patients at almost 90 clinical sites in Australia, Europe, Israel and North America. The company expects to report top line results in mid-2015, following a six month follow up period for all patients.
Over 1.9 million patients suffer a heart attack in the United States and European Union each year of which approximately 35-40% develop congestive heart failure within five years of the event. BCM is intended to prevent congestive heart failure after a heart attack.
The PRESERVATION I clinical trial is a CE Mark registration trial in the European Union. If the results of this trial are positive, the company expects it would form the basis for its CE marking application. In addition, the company would expect to conduct a second, larger clinical trial to support approval in the United States through the premarket approval (PMA) pathway.
This ongoing study is being conducted as a randomized, double-blind, placebo-controlled trial. The purpose of the study is to evaluate the safety and efficacy of BCM for the prevention of ventricular remodeling and congestive heart failure when administered to subjects who had successful percutaneous coronary intervention (PCI) with stent placement after ST-Elevation Myocardial Infarction (STEMI), a type of severe heart attack.
The primary endpoint is a change in Left Ventricular End Diastolic Volume Index (LVEDVI) at six months compared to baseline. LVEDVI is an anatomic measurement of ventricular remodeling assessed through echocardiogram.
Secondary endpoints include patient-reported assessment of symptoms, function, and quality of life (Kansas City Cardiomyopathy Questionnaire), functional capacity (Six Minute Walk Test), physician-assessed function (New York Heart Association Functional Classification), and cardiovascular events (death, hospitalization, and time to hospitalization).