BROOMFIELD, Colo.--(BUSINESS WIRE)--ARCA biopharma, Inc. (Nasdaq: ABIO) today announced that it has submitted a study protocol for review under the U.S. Food and Drug Administration’s (FDA) Special Protocol Assessment (SPA) process for the design of a clinical trial to assess the safety and efficacy of GencaroTM, in approximately 3,000 patients with chronic heart failure who have the genotype that appears to respond most favorably to Gencaro. Gencaro is the Company’s investigational, pharmacologically unique beta-blocker and mild vasodilator. The FDA has previously designated the investigation of Gencaro for the reduction of cardiovascular mortality and cardiovascular hospitalizations in a genotype-defined heart failure population as a fast-track development program. An SPA is an agreement with the FDA that the proposed trial protocol design, clinical endpoints and statistical analyses are acceptable to support regulatory approval. For further information, please visit the FDA website, www.fda.gov.
