ARCA Biopharma announces GENETIC-AF trial data published

ARCA Biopharma announced that GENETIC-AF data was published in JACC: Heart Failure, a journal of the American College of Cardiology. Bucindolol is a beta-blocker whose unique pharmacologic properties provide greater benefit in HF patients who have the beta-one adrenergic receptor, or ADRB1, Arg389Arg genotype. GENETIC-AF compared the effectiveness of bucindolol and metoprolol succinate for the maintenance of sinus rhythm in a genetically-defined HF population with AF. The trial enrolled 267 HF patients with a left ventricular ejection fraction, or LVEF, less than 0.50, symptomatic AF, and the ADRB1 Arg389Arg genotype. The primary endpoint of AF/atrial flutter, or AFL, or all-cause mortality, or ACM, was evaluated by electrocardiogram during a 24-week period. The hazard ratio, or HR, for the primary endpoint was neutral, but trends for bucindolol benefit were observed in several subpopulations. Precision therapeutic phenotyping revealed that a differential response to bucindolol was associated with: the interval of time from the initial diagnosis of HF and AF to randomization, and: the onset of AF relative to initial HF diagnosis. In a cohort whose first HF and AF diagnoses were less than 12 years prior to randomization, in which AF onset did not precede HF by more than 2 years, the HR was 0.54. Moreover, in the HF with mid-range LVEF subpopulation, which comprised approximately 50% of randomized patients, the HR was 0.42. As expected based on its unique pharmacology, bucindolol reduced plasma venous norepinephrine levels while metoprolol did not. Plasma NT-proBNP, a biomarker of both AF and HF, was reduced in the bucindolol group at 4 weeks, 12 weeks and 24 weeks while in the metoprolol group a reduction was observed only at 24 weeks.

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