ARCA biopharma, Inc. (NASDAQ:ABIO), a biopharmaceutical company applying a precision medicine approach to the development of genetically-targeted therapies for cardiovascular diseases, today announced the randomization of the first European patients in the GENETIC-AF Phase 2B/3 clinical trial. GENETIC-AF, which has been enrolling patients in the United States and Canada, is evaluating GencaroTM as a potential treatment for atrial fibrillation (AF). Last week, ARCA hosted a GENETIC-AF European Investigator Meeting which brought together European physicians and research coordinators for study-specific training and information sharing. It is estimated that approximately six million patients in Europe have atrial fibrillation.
ARCA is evaluating Gencaro, a pharmacologically unique beta-blocker and mild vasodilator, as a potential treatment for AF in the GENETIC-AF Phase 2B/3 clinical trial. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically-targeted therapy for the prevention of atrial fibrillation.
“We are excited to expand the GENETIC-AF trial to European investigative sites that have expressed interest in participating in the on-going trial,” said Michael R. Bristow, President and Chief Executive Officer. “We expect that the additional investigative sites in certain European countries will support the latter part of Phase 2B, and potentially the Phase 3 stage, of the trial. We believe inclusion of European investigative sites may also support potential European regulatory submissions and on-going business development activity.”
Based on the current enrollment rate, the Company expects to randomize at least 150 patients into the trial by the end of 2016. The GENETIC-AF Data Safety Monitoring Board (DSMB) will conduct an interim efficacy, safety and futility analysis of data from at least 150 patients with evaluable data. The Company expects the outcome of this interim analysis in the second quarter of 2017.
About ARCA biopharma
ARCA biopharma is dedicated to developing genetically-targeted therapies for cardiovascular diseases through a precision medicine approach to drug development. The Company’s lead product candidate, GencaroTM (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for atrial fibrillation. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically-targeted atrial fibrillation prevention treatment. ARCA has a collaboration with Medtronic, Inc. for support of the GENETIC-AF trial. For more information, please visit www.arcabio.com.
