ARCA Biopharma has announced that the 100th patient has been randomised into GENETIC-AF, a seamless design phase 2B/3 clinical trial evaluating Gencaro (bucindolol hydrochloride) as a potential treatment for atrial fibrillation. This represents two-thirds of the minimum number of patients needed for a pre-specified Phase 2B interim efficacy analysis.
Based on the current enrolment rate, the company expects to randomise at least 150 patients into the trial by the end of 2016. The GENETIC-AF Data Safety Monitoring Board (DSMB) will conduct an interim efficacy, safety and futility analysis of data from at least 150 patients with evaluable data. The company expects the outcome of this interim analysis in the second quarter of 2017.
GENETIC-AF clinical trial
GENETIC-AF is a phase 2B/Phase 3, multicentre, randomised, double-blind, adaptive design clinical trial comparing the safety and efficacy of Gencaro to Toprol-XL (metoprolol succinate) for the treatment of atrial fibrillation in approximately 620 patients. Eligible patients will have heart failure with reduced left ventricular ejection fraction, have a history of paroxysmal AF (episodes lasting seven days or less) or persistent AF (episodes lasting more than seven days and less than one year) in the past six months, and have the beta-1 389 arginine homozygous genotype that the company believes responds most favorably to Gencaro. The primary endpoint of the study is time to first event of symptomatic atrial fibrillation/atrial flutter or all-cause mortality. The trial is currently enrolling patients in the United States and Canada.