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Unmet Medical Need In Treatment Of Heart Failure Patients With Atrial Fibrillation Highlighted In Articles In Inaugural Issue Of JACC: Heart Failure

ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically-targeted therapies for atrial fibrillation, heart failure and other cardiovascular diseases, today announced that the editorial “Treatment of the Heart Failure Patient with Atrial Fibrillation: A Major Unmet Need” was published in the first edition of JACC: Heart Failure, a new journal of the American College of Cardiology ( http://heartfailure.onlinejacc.org/article.aspx?articleid=1568319).

The editorial, authored by ARCA’s President and Chief Executive Officer, Dr. Michael Bristow, and Dr. Ryan Aleong of the University of Colorado, discusses the authors’ views that the treatment of atrial fibrillation (“AF”) in heart failure (“HF”) patients with reduced left ventricular ejection fractions (“HFREF”) is a major unmet need in cardiovascular therapies and should be approached differently from current treatments for HFREF patients with sinus rhythm.

The article is an accompanying editorial to “Beta-Blockers and Outcome in Heart Failure and Atrial Fibrillation: A Meta-Analysis,” by Michiel Rienstra, MD, et al. ( http://heartfailure.onlinejacc.org/article.aspx?articleid=1568318), in the same edition of JACC: Heart Failure, which examined the results of four major Phase 3 HFREF trials of the four beta-blockers (carvedilol, metoprolol, bisoprolol and nebivolol) that are currently approved for the treatment of HF. The authors of the meta-analysis report conclude that the evidence indicates that the evaluated beta-blockers provided little or no benefit to HFREF patients with AF in these trials.

The Rienstra report did not include data from the published Phase 3 clinical study of Gencaro (bucindolol hydrochloride) known as the Beta Blocker Evaluation of Survival Trial (“BEST”) ( http://www.ncbi.nlm.nih.gov/pubmed/23223178). The Bristow/Aleong editorial comments that the data from BEST appear to be different from the data for the drugs evaluated in the Rienstra study, because retrospective analyses of the data from BEST appear to show evidence of efficacy for Gencaro in HFREF patients with AF, and enhanced efficacy for those HFREF patients with AF who possess a common genetic variant in the cardiac beta-1 adrenergic receptor (AR), the primary drug target of beta-blockers for cardiovascular indications.

The editorial authors discuss several reasons why the data for Gencaro in HFREF patients with AF appear to be different from that for the beta-blockers analyzed in the Rienstra paper, including Gencaro’s unique mechanisms of action. The editorial also notes that the use of anti-arrhythmic drugs to treat AF in HFREF patients is problematic due to the high frequency of pro-arrhythmia and adverse effects on left ventricular function associated with these drugs. The authors highlight the potential significance of the medical need represented by HFREF patients with AF, noting that the two diseases commonly occur together (19% of the HFREF patients in the trials analyzed by Rienstra had AF and other reports have estimated up to 40% of HFREF patients have AF), and the evidence that AF worsens mortality in HFREF patients. The editorial concludes by stating: "At a minimum, . . . AF-HFREF treatment should be approached differently from that for SR-HFREF, via therapies uniquely suited to dealing with this important subpopulation."

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