BioCentury
ARTICLE | Clinical News

Arca reports Phase IIb data for Gencaro in heart failure patients

March 2, 2018 8:50 PM UTC

Arca biopharma Inc. (NASDAQ:ABIO) reported top-line data from the Phase IIb GENETIC-AF trial in 267 heart failure patients with reduced left ventricular ejection fraction (LVEF) showing that Gencaro bucindolol hydrochloride led to a "similar treatment benefit" on the primary endpoint compared to Toprol-XL metoprolol succinate. The primary endpoint is the time to recurrent atrial fibrillation (AF), atrial flutter or all-cause mortality.

Arca said the trial was not powered for "conventional significance" and used Bayesian statistical modeling to determine the predictive probability of success (PPoS) on the primary endpoint if the trial had enrolled 620 patients with 330 primary events. In the 267 patients, the company said the PPoS was 14% based on 143 total events (HR=1.01, 95% CI: 0.71, 1.42)...