Gencaro Data in Atrial Fibrillation
Clinical data from BEST, a Phase 3 trial in 2,708 patients with advanced heart failure, indicate that Gencaro may have a potentially enhanced and pharmacogenetically-influenced effect in reducing and preventing atrial fibrillation. In that trial, patients in the Gencaro arm demonstrated a reduction in the risk of new onset atrial fibrillation time to event compared to patients in the placebo arm of 41% (atrial fibrillation measured as an adverse event/serious adverse event or as detected on surveillance ECGs, time to event analysis, p = 0.0004). In a 1,040 patient DNA substudy of BEST, Gencaro exhibited pharmacogenetic enhancement and differentiation for atrial fibrillation prevention in patients with a specific genotype (beta 1389 arginine homozygous (Arg/Arg) adrenergic receptor (AR); approximately 47% of the patients). These patients experienced a 74% (p = 0.0003) reduction in risk of atrial fibrillation versus no detectable reduction in patients who had alternative genotypes (beta 1389 Gly carriers; 53% of the patients). The Company believes this data supports the potential ability of Gencaro to prevent atrial fibrillation in patients who have the genotype the Company believes responds most favorably to Gencaro.
In prior placebo controlled trials in chronic HFREF, most studies comparing beta-blockers to placebo have detected a positive signal for prevention of atrial fibrillation, with an event rate reduction averaging approximately 27%, even though atrial fibrillation had not been a pre-specified primary or secondary endpoint in these studies. Currently, no beta-blocker has been approved by the U.S. Food and Drug Administration for the prevention of atrial fibrillation in heart failure patients.
Gencaro Phase 3 Atrial Fibrillation Clinical TrialThe Company plans to conduct a Phase 3, multi-center, randomized, double-blind clinical trial of Gencaro in approximately 300-400 new onset atrial fibrillation patients with HFREF. The Company believes the planned study will provide important clinical data on the safety and efficacy of Gencaro in this patient population and additional information on the pharmacogenetic selectivity of Gencaro. The primary endpoint of the trial will be time to recurrent symptomatic atrial fibrillation after electrical cardioversion. The atrial fibrillation development program was recently presented by Dr. Bristow at the Heart Failure Congress 2011, organized by the Heart Failure Association of the European Society of Cardiology.