ARCA Bio reports randomization of first European patients in Phase 2b/3 trial
ARCA biopharma 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 Gencaro as a potential treatment for atrial fibrillation. 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. 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 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.