ARCA biopharma has announced the completion of enrolment for GENETIC-AF. This Phase 2B, double-blind, superiority clinical trial is evaluating bucindolol hydrochloride (Gencaro) as a potential genetically-targeted treatment for atrial fibrillation (AF). ARCA expects to report top-line Phase 2B data late in the first quarter of 2018.
Two-hundred and sixty-seven patients were randomised into the trial, slightly exceeding the target enrolment of 250 patients. The trial enrolled patients from the USA, Canada and Europe.
“We look forward to reporting top-line data for the trial, which we estimate should include approximately 50% more events than were available at the recently conducted interim analysis,” comment Michael Bristow, ARCA’s president and chief executive officer. “I would like to thank our clinical investigators as well as the patients and their families for their participation. We will continue working diligently to advance bucindolol hydrochloride’s pharmacogenetic clinical and regulatory development.
GENETIC-AF is a clinical trial comparing the safety and efficacy of bucindolol hydrochloride to metoprolol succinate for the treatment and prevention of recurrent atrial fibrillation or flutter in heart failure patients with reduced left ventricular ejection fraction (HFrEF).
Eligible patients have HFrEF, 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 the beta-1 389 arginine homozygous genotype that ARCA believes responds most favourably to bucindolol hydrochloride.
The GENETIC-AF Data and Safety Monitoring Board (DSMB) conducted a pre-specified interim analysis of all patients randomised as of 19 June 2017. Based on its efficacy and safety review, the DSMB recommended completion of the Phase 2B trial with no changes to the trial design and indicated that there were no safety concerns.