Gencaro bucindolol: Phase IIb/III start

Next quarter, Arca biopharma will begin the double-blind, placebo-controlled, U.S. Phase IIb/III GENETIC-AF trial to compare 6.25, 12.5, 25, 50 and 100 mg oral Gencaro twice daily vs. 25, 50, 100 and 200 mg oral Toprol-XL metoprolol succinate twice daily in about 620 patients with a genetic variant of ADRB1 who have heart failure and reduced left ventricular ejection fraction (LVEF). The Phase IIb portion will enroll about 200 patients, and the Phase III portion will enroll an additional 420 patients. Arca will also conduct a substudy with Medtronic to continuously monitor cardiac rhythms of all patients in the Phase IIb portion. The substudy will measure AF burden, defined as a patient's actual time in AF regardless of symptoms. ...