Phase III data on Gencaro (ARCA biopharma) shows drug effective on genetic subset of Atrial Fibrillation patients

New results of a Phase III trial of Gencaro (bucindolol hydrochloride), from ARCA biopharma, in reducing the incidence of new onset Atrial Fibrillation in patients with advanced heart failure with reduced left ventricular ejection fraction (HFREF) show the drug offers significant benefits to a subset of patients. The study was based on a post-hoc analysis of 2,708 HFREF patients known as the BEST Trial, which analyzed Gencaro's potential efficacy in reducing the risk of developing new onset AF.

Patients who had received Gencaro had a 41% lower risk of new onset AF compared to patients who received a placebo. However, the risk of new onset AF was reduced by 74% compared to placebo in those patients in the DNA substudy who received Gencaro and who possessed the beta-1 AR position 389 arginine homozygous (beta-1 389 arginine homozygous) genotype. The beta-1 389 arginine homozygous genotype is present in about 50% of the general US population. The company plans to assess Gencaro's potential efficacy in the Phase IIb/III GENETIC-AF clinical trial, in beta-1 389 arginine homozygous HFREF patients, post electrical cardioversion for persistent AF. Data was published in JACC: Heart Failure. See :"Prevention of Atrial Fibrillation by Bucindolol is Dependent on the Beta-1 389 Arg/Gly Adrenergic Receptor Polymorphism" Ryan G. Aleong et al. JCHF May 2013; doi:10.1016/j.jchf.2013.04.002