WESTMINSTER, Colo.—ARCA biopharma Inc., a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, in mid-November presented data from the atrial fibrillation burden (AFB) substudy of its Phase 2B GENETIC-AF clinical trial in a poster session at the American Heart Association (AHA) 2018 Scientific Sessions in Chicago. Presenting the data was Dr. Jonathan Piccini, associate professor of medicine and director of the Duke Center for Atrial Fibrillation at Duke University Medical Center.
GENETIC-AF was a Phase 2B, double-blind, superiority clinical trial evaluating Gencaro (bucindolol hydrochloride) as a genetically targeted treatment for atrial fibrillation (AF) in patients with heart failure and reduced left ventricular ejection fraction (HFrEF). Safety data indicated that Gencaro was generally safe and well tolerated in the AF/HFrEF population investigated, with a safety profile similar to the active comparator metoprolol succinate (Toprol XL).
The primary endpoint results for the trial were determined by intermittent, clinic-based heart rhythm monitoring. However, a subset of patients also underwent continuous heart rhythm monitoring with Medtronic-implanted devices to determine AF recurrence based on AFB. In this substudy, Gencaro demonstrated similar trends for benefit compared to Toprol XL for the endpoint of time to AF recurrence when measured by continuous monitoring with implanted devices and by intermittent ECG-based monitoring. Analyses were also presented for a cohort that excluded patients with long-standing (i.e., ≥12 years) and heavily pretreated HF and/or AF. In these analyses, a trend for benefit in favor of Gencaro over Toprol XL was observed in the overall population and in the AFB substudy population using device-based detection.