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ARCA Biopharma Announces First Quarter 2020 Financial Results And Provides Corporate Update
U.S. FDA Special Protocol Assessment agreement for PRECISION-AF, a single pivotal Phase 3 clinical trial of genetically targeted GencaroPRECISION-AF trial to
About this update from Oruka Therapeutics, Inc.
[{"type":"text","content":"U.S. FDA Special Protocol Assessment agreement for PRECISION-AF, a single pivotal Phase 3 clinical trial of genetically targeted GencaroPRECISION-AF trial to evaluate Gencaro as a potential treatment for prevention of atrial fibrillation in a heart failure population for which there are no FDA indicated drug therapiesPRECISION-AF clinical trial initiation anticipated fourth quarter WESTMINSTER, Colo., May 06, 2020 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today reported financial results for the first quarter of 2020 and provided a corporate update.\n\n \n \n \n \n \n \n \n \n \n \n \n Dr. Michael Bristow, President and CEO, ARCA biopharma, Inc.\n \n \n \n \n \n \n \n \n\n Dr. Michael Bristow, ARCA’s President and Chief Executive Officer, commented, “During this time of national and global health crisis, ARCA has acted to address uncertainty with a focus on three key areas: protecting the health and well-being of our employees, continuing effective operations to support advancing the development of Gencaro as a potential genetically targeted treatment for heart failure patients with atrial fibrillation, and seeking additional funding, whether through direct financing or on-going partnering discussions. Our planned Phase 3 clinical trial addresses a patient population for which there are currently no FDA approved drug therapies and we believe Gencaro has the potential to help address this substantial unmet medical need.” Pipeline Update Gencaro™ (bucindolol hydrochloride) - a pharmacologically unique beta-blocker and mild vasodilator being developed as a potential genetically targeted treatment for atrial fibrillation (AF) in patients with heart failure (HF). The U.S. Food and Drug Administration (FDA) issued a Special Protocol Assessment (SPA) agreement for a single Phase 3 clinical trial (PRECISION-AF) to examine Gencaro as a genetically targeted therapy for the prevention of AF recurrence in certain heart failure patients.PRECISION-AF is designed as a double-blind, active-controlled, multicenter, international, adaptive study comparing Gencaro with TOPROL-XL (metoprolol succinate) for the prevention of AF recurrence or all-cause mortality in approximately 400 heart failure ...