January 16, 2015 — Bellerophon Therapeutics LLC said it 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). The 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 percent 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). 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, functional capacity, physician-assessed function and cardiovascular events.
For more information: www.bellerophon.com