Clinical stage biotherapeutics company Bellerophon Therapeutics, Inc. has just revealed the top-line results of its PRESERVATION I clinical study for Bioabsorbable Cardiac Matrix (BCM), an experimental, implantable medical device currently being advanced as a potential preventive measure against heart failure in the event of an acute myocardial infarction.
PRESERVATION I is a randomized, double-blind, placebo-controlled clinical trial that enrolled 303 patients at 61 clinical sites across Australia, Europe, Israel and North America. The findings failed to show any notable difference in treatment response between the experimental and control group when evaluated against both primary and secondary endpoints. BCM’s safety profile was also found to be unremarkable compared to those in the placebo group. These findings will be presented during this year’s European Society of Cardiology meeting in London, on September 1.
Jonathan Peacock, Chairman and Chief Executive Officer of Bellerophon Therapeutics, noted, “We are clearly disappointed with the topline results from PRESERVATION I and will continue to investigate the full data set over the next few weeks and to reassess further clinical development of BCM. We continue to be enthusiastic about our pulmonary hypertension pipeline which leverages years of experience with Nitric Oxide therapy and a novel and proprietary delivery system for outpatient use. Of note, we are preparing to initiate the first of two Phase 3 trials for INOpulse® for the treatment of pulmonary arterial hypertension (PAH), a chronic and debilitating disease. We had approximately $50 million of cash on our balance sheet as of June 30, 2015 to fund this Phase 3 trial and we expect to enroll our first patient by the end of 2015. In addition, we are continuing to investigate the application of INOpulse for the treatment of pulmonary hypertension associated with COPD and Pulmonary Fibrosis”.
In an earlier report, an international team led by researchers at the University Hospital Heidelberg in Germany recently revealed that stress-doppler-echocardiography, a procedure based on ultrasound technology, is effective in early detection of pulmonary arterial hypertension in patients with systemic sclerosis. The study was published in the journal Arthritis Research and Therapy and is entitled “Stress-Doppler-Echocardiography for early detection of systemic sclerosis associated pulmonary arterial hypertension.”