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ARCA Biopharma announces data from AFB substudy of GENETIC-AF trial at AHA.

ARCA Biopharma announced that data from the Atrial Fibrillation Burden, or AFB, substudy of the Phase 2B GENETIC-AF clinical trial were presented in a poster session at the American Heart Association, or AHA. GENETIC-AF was a Phase 2B, double-blind, superiority clinical trial evaluating Gencaro as a genetically-targeted treatment for atrial fibrillation, or AF, in patients with heart failure and reduced left ventricular ejection fraction, or 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. 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, a method that can identify AF with more certainty than intermittent clinic-based monitoring. A prespecified time-to-first event analysis was conducted using a total AFB of at least 6 hours per day to define an event of AF recurrence, as this criterion has been previously shown to be associated with an increased rate of HF hospitalizations. 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. Event rates were slightly higher for device-based monitoring and the device-based endpoint occurred a median of 6.5 days prior to ECG-based detection. Analyses were also presented for a cohort that exclude patients with long-standing 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 and ECG-based detection.

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Publication:The Fly
Date:Nov 12, 2018
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