Bellerophon Therapeutics has announced top-line results from its PRESERVATION I clinical trial for Bioabsorbable Cardiac Matrix (BCM), an investigational, implantable medical device being studied for the prevention of heart failure following an acute myocardial infarction.
Top line results of the 303-patient, randomised, double-blind, placebo-controlled study, enrolled at 61 clinical sites in Australia, Europe, Israel and North America, showed no statistically significant treatment differences between patients treated with BCM and patients treated with placebo for both the primary and the secondary endpoints.
Safety data analysed to date shows no significant difference in adverse event rates for patients in the BCM and placebo treatment groups.
The company plans to present detailed results from the trial at the European Society of Cardiology meeting (29 August–1 September, London, UK).
Jonathan Peacock, chairman and chief executive officer of Bellerophon Therapeutics, noted, “We are clearly disappointed with the top line 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.”
Peacock continued, “Of note, we are preparing to initiate the first of two phase 3 trials for INOpulse for the treatment of pulmonary arterial hypertension, a chronic and debilitating disease. We had approximately US$50m in cash on our balance sheet as of June 30, 2015 to fund this phase 3 trial and we expect to enrol 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 chronic obstructive pulmonary disease and pulmonary fibrosis.”