Broomfield / Colorado / United States
ARCA biopharma, Inc., is dedicated to developing and commercializing genetically targeted therapies for heart failure and other cardiovascular disease. The companys lead product candidate, Gencaro (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for heart failure and other indications. 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 heart failure treatment. The New Drug Application for approval of Gencaro for the indication of chronic heart failure, including the proposed brand name, is currently under review by the U.S. Food and Drug Administration with a Prescription Drug User Fee Act (PDUFA) date of May 31, 2009. ARCA is collaborating with Laboratory Corporation of America to develop the companion genetic test for Gencaro. The Company s second compound in development, NU172, is a direct thrombin inhibitor that has completed Phase 1b development for use as a potential short-acting anticoagulant during medical or surgical procedures.
