Arca biopharma reports overall survival benefit from heart failure trial

Arca biopharma has reported data from the pivotal Phase III Best trial of Gencaro in patients with advanced chronic heart failure. The trial results demonstrated that, in a demographically diverse group of primarily US patients with New York Heart Association class III and IV heart failure, Gencaro treatment resulted in a near significant overall survival benefit and statistically significant benefits in slowing progression of heart failure, the company said.

The results were observed despite the premature termination of the trial, with only 92% of the projected primary endpoint events available and average follow-up shortened by 12 months, said Arca biopharma.

Analyzed in accordance with the FDA-reviewed, pre-specified statistical analysis plan, the primary endpoint of mortality was reduced in all Best trial patients on Gencaro by 13% (hazard ratio (HR) 0.87; p=0.053).

All eight secondary endpoints of the trial were positive and statistically significant. As pre-specified with the FDA, the composite endpoint of heart failure progression was the most important secondary endpoint, with Gencaro shown to be superior to placebo for slowing progression of heart failure (HR 0.80, p=0.00003), and for the endpoint’s components of heart failure-related mortality (HR 0.85, p=0.042), heart failure-related hospital admission (HR 0.77, p=0.00002), and heart failure-related emergency room visits (HR 0.74, p=0.024).

Best was a randomized, placebo-controlled trial in patients with moderate to severe heart failure (New York Heart Association class III or IV), testing the hypothesis that beta-blockers reduce mortality and morbidities in patients with heart failure. Best was jointly funded by the Veteran’s Administration Cooperative Clinical Studies Program and the National Heart, Lung and Blood Institute. As a result of the quality of data from existing studies in patients with heart failure and its tolerability, Gencaro was chosen as the beta-blocker for evaluation in this trial, said Arca biopharma.

Michael Bristow, founder and chief science and medical officer of Arca biopharma, said: The results of the Best trial, analyzed according to the pre-specified regulatory statistical analysis plan, are the foundation of our new drug application currently under review by the FDA with a Prescription Drug User Fee Act date of May 31, 2009. We believe there is a substantial need for new heart failure therapies for which response can be better predicted pharmacogenetically prior to the onset of therapy, and that Gencaro may help to address these needs.