ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically targeted therapies for cardiovascular diseases, today announced that the first patient has been genetically screened in GENETIC-AF, its Phase 2B/3 adaptive design clinical trial. The GENETIC-AF trial will evaluate GencaroTM (bucindolol hydrochloride) as a potential treatment for the prevention of atrial fibrillation (AF) in patients with heart failure and/or left ventricular dysfunction who also have a specific genotype of the beta-1 adrenergic receptor (389 arginine homozygous), which is believed to be present in approximately 50% of the U.S. population. There are currently seven active clinical trial sites recruiting patients for GENETIC-AF. The Company anticipates having approximately 50 clinical trial sites for the Phase 2B portion of the trial. Last week, ARCA hosted the initial GENETIC-AF Investigator Meeting which brought together the physicians and research coordinators participating in the trial for information sharing and study-specific training.
Gencaro is an investigational, pharmacologically unique beta-blocker and mild vasodilator. ARCA has identified common genetic variations that it believes may predict individual patient response to Gencaro, giving it the potential to be the first genetically targeted AF prevention treatment. Currently, no beta-blocker has been approved by the U.S. Food and Drug Administration for the prevention of AF.
AF is considered an epidemic cardiovascular disease. The estimated number of individuals with AF globally in 2010 was 33.5 million. According to the 2014 American Heart Association report on Heart Disease and Stroke Statistics, the estimated number of individuals with AF in the U.S. in 2010 ranged from 2.7 to 6.1 million. AF increases the risk of stroke and may also contribute to worsening heart failure.
"This is a major milestone for the company and for the development of Gencaro," said Dr. Michael R. Bristow, President and Chief Executive Officer of ARCA. "We believe we have an opportunity to potentially improve the treatment options for patients at risk for, or living with, atrial fibrillation by addressing an unmet medical need in patients who also have heart failure and/or left ventricular dysfunction. The Gencaro development program, if successful in GENETIC-AF, would also herald a new era of pharmacogenetically developed cardiovascular drugs."
ARCA and Medtronic, Inc. (NYSE: MDT), a leader in medical technologies to improve the treatment of chronic diseases, including cardiac rhythm disorders, entered into a collaboration agreement in May 2013 to support GENETIC-AF.
Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH) and ARCA have collaborated to develop a companion diagnostic for identifying prospective patients' genotypes. LabCorp is conducting the genotyping for the GENETIC-AF trial.