ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today announced that it is planning to expand the development of Gencaro, its lead cardiovascular drug candidate, to atrial fibrillation, a disease that affects more than 2.4 million patients in the United States. Subject to obtaining additional funding, the Company anticipates initiating patient enrollment of a Phase 3 clinical trial in the first half of 2012 to evaluate Gencaro in patients who have symptomatic atrial fibrillation and heart failure with reduced left ventricular ejection fraction (HFREF).
“At ARCA, we believe a personalized medicine approach to drug development, tailoring medical treatment to the individual genetic characteristics of each patient, can enable more effective therapies, improve patient outcomes and reduce healthcare costs,” said Dr. Michael R. Bristow, President and Chief Executive Officer of ARCA. “If our development program for Gencaro in atrial fibrillation successfully confirms atrial fibrillation data from the prior BEST study, Gencaro has the potential to be the first genetically targeted treatment for the prevention of this important cardiovascular disorder.”
Atrial fibrillation is a disorder in which the normally regular and coordinated contraction pattern of the heart's two small upper chambers (the atria) becomes irregular and uncoordinated. The irregular contraction pattern associated with atrial fibrillation causes blood to pool in the atria, predisposing the formation of clots. These clots may travel from the heart and become lodged in the arteries leading to the brain and other organs, thereby blocking necessary blood flow and potentially resulting in stroke. In addition, in patients with HFREF, new onset atrial fibrillation may also contribute to worsening heart failure and increased risk of death.
Studies estimate atrial fibrillation affected between 2.4 and 3 million Americans in 2005. Those same studies estimate the prevalence of atrial fibrillation will likely increase to between 3.8 million and 4.8 million by 2025. Industry estimates expect the atrial fibrillation drug market in developed countries to increase more than eight-fold, from $843 million in 2009 to $6.8 billion in 2019. The Company believes there is an unmet medical need for new atrial fibrillation treatments that have fewer side effects than currently available therapies and are more effective, particularly in patients with HFREF, where most of the approved atrial fibrillation drugs are contra-indicated or have warnings in their prescribing information.