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ARCA Biopharma Announces Third Quarter 2019 Financial Results and Provides Corporate Update
PRECISION-AF pivotal Phase 3 clinical trial initiation anticipated first quarter of 2020Trial to examine atrial fibrillation in a heart failure population for
About this update from Oruka Therapeutics, Inc.
[{"type":"text","content":"PRECISION-AF pivotal Phase 3 clinical trial initiation anticipated first quarter of 2020Trial to examine atrial fibrillation in a heart failure population for which there are no FDA indicated drug therapies WESTMINSTER, Colo., Nov. 06, 2019 (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 quarter ended September 30, 2019 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 “There are currently no FDA approved drug therapies indicated for treating patients with atrial fibrillation and heart failure with left ventricular ejection fraction values greater than 40%,” commented Dr. Michael Bristow, ARCA’s President and Chief Executive Officer. “Approximately two-thirds of all heart failure patients have LVEF values greater than 40% and about half of these patients will develop atrial fibrillation. Based on our Phase 2 data, we believe Gencaro has the potential to help address this substantial unmet medical need. We look forward to further evaluating Gencaro in the planned Phase 3 clinical trial, PRECISION-AF, which we plan to initiate in the first quarter of 2020.” Pipeline Update GencaroTM (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). In July 2019, the U.S. Food and Drug Administration (FDA) agreed to amend ARCA’s Special Protocol Assessment (SPA) agreement for the Phase 3 PRECISION-AF clinical trial to expand the target trial population to include heart failure patients with left ventricular injection fractions (LVEF) > 40% and In September 2019, Gencaro AF clinical data from the GENETIC-AF Phase 2B trial was presented at the Heart Failure Society of America (HFSA) 2019 Annual Scientific Meeting. The data indicate Gencaro response appears to be greater in HF patients with less severe left ventricular dysfunction, a patient population with no FDA approved drug therapeutic options for AF prevention or heart failure. AB171 – a thiol-substituted isosorbide mononitrate being dev...