Bellerophon’s BCM Heart Device Falters in Clinical Trial
Bellerophon Therapeutics’ Bioabsorbable Cardiac Matrix showed no statistically significant advantage over placebo in preventing heart failure after a heart attack in a pivotal Phase 3 clinical trial, the company said Monday.
The implantable BCM failed to meet both its primary and secondary endpoints in the PRESERVATION I trial.
The primary endpoint was change in left ventricular diastolic volume index at six months compared with baseline. The secondary endpoints were Kansas City Cardiomyopathy Questionnaire, six-minute walk test, New York Heart Association functional classification, time to cardiovascular death or nonfatal heart failure or cardiovascular hospitalizations and time to first rehospitalization following a cardiac event.
Additionally, safety data showed no significant difference in adverse events for both study arms. In total, 303 patients were enrolled across 61 sites in Australia, Europe, Israel and North America.
Chairman and CEO Jonathan Peacock said the company is disappointed with the study’s results and will investigate the full data set over the next few weeks. — Jason Scott