Business
ARCA biopharma Announces Fiscal Year 2019 Financial Results and Provides Corporate Update
U.S. FDA Special Protocol Assessment agreement for a single pivotal Phase 3 clinical trial (PRECISION-AF) of genetically-targeted GencaroPRECISION-AF clinical
About this update from Oruka Therapeutics, Inc.
[{"type":"text","content":"U.S. FDA Special Protocol Assessment agreement for a single pivotal Phase 3 clinical trial (PRECISION-AF) of genetically-targeted GencaroPRECISION-AF clinical trial initiation anticipated fourth quarter of 2020Trial 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 therapies WESTMINSTER, Colo., Feb. 18, 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 year ended December 31, 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 Dr. Michael Bristow, ARCA’s President and Chief Executive Officer, commented, “During 2019, we continued to advance development of Gencaro as a potential genetically-targeted treatment for heart failure patients with atrial fibrillation. In published or submitted for presentation/publication material, we have identified important new effectiveness evidence from the GENETIC-AF trial that have enhanced our understanding of the clinical profile of Gencaro. These data have allowed us to broaden the design of the single, pivotal Phase 3 clinical trial that was developed after consultation with the U.S. Food and Drug Administration via a Special Protocol Assessment agreement. There are currently no FDA approved drug therapies indicated for the treatment of atrial fibrillation in heart failure patients with left ventricular ejection fraction values greater than 40%. Based on our clinical data to date, we believe Gencaro has the potential to help address this substantial unmet medical need. We look forward to further evaluating the pharmacogenetic benefits of Gencaro for patients with our targeted genetic profile in PRECISION-AF, the Phase 3 clinical trial, which, subject to obtaining additional financing, we plan to initiate in the fourth quarter of 2020.” Pipeline Update – Second Half Review 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...