ARCA Submits New SPA (NASDAQ:ABIO)

ARCA Biopharma, Inc (NASDAQ:ABIO) has announced that they have submitted a study protocol for review under Food and Drug Administration’s Special Protocol Assessment (SPA) process for the design of a clinical trial to assess the safety and efficacy of Gencaro. Gencaro is the Company’s investigational, pharmacologically unique beta-blocker and mild vasodilator and it will be used on approximately 3,000 patients with chronic heart failure who have the genotype that appears to respond most favorably to Gencaro. Gencaro is an oral tablet formulation, dosed twice daily and because of its mild vasodilator effects, the Company believes Gencaro is well-tolerated in patients with advanced heart failure.

ARCA Biopharma is dedicated to developing genetically targeted therapies for heart failure and other cardiovascular disease. The Company 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. Special Protocol Assessment also known as SPA is an agreement with the FDA that the proposed trial protocol design, clinical endpoints and statistical analyses are acceptable to support regulatory approval.

Announcing about the submission of this SPA, CEO and President of ARCA Biopharma, Michael Bristow said that the submission of their trial protocol for review under the FDA’s SPA process is an important milestone for ARCA as well as for Gencaro and that they believe that Gencaro has the potential to provide a needed advancement in the treatment of patients with chronic heart failure, a disease afflicting approximately 6 million people in the United States of America.