ARCA Biopharma Inc. (NASDAQ: ABIO) has announced the publication of a paper detailing the latest analysis of the Gencaro Phase IIb data on atrial fibrillation burden and rhythm management interventions. The paper titled Bucindolol [Gencaro] Decreases AF Burden by JInathnsPiccini et al. was published on the American Heart Association journal’s Circulation; Arrhythmia and Electrophysiology.
Results show Gencaro minimized AF burden
Although the predetermined primary endpoint was not achieved in the Phase 2b superiority clinical trial, Gencaro minimized AF burden and increased sinus rhythm maintenance. Equally, it eliminated the need for further rhythm control interventions in heart failure (HF) patients and the genotype that responds favorably to Gencaro when compared to metoprolol.
The whole population entering efficacy follow-up (N=257) was analyzed for electrocardiograms (ECGs) prevalence in normal sinus rhythm, AF rhythm control interventions (catheter ablation, electrical cardioversion, and Class III antiarrhythmic medications), and biomarkers. In addition, in a device substudy (N=67), AF load was assessed for 24 weeks while all patients had continuous heart rhythm monitoring via implanted devices.
The first author of the paper, Jonathan Piccini, explained, “Atrial fibrillation in heart failure patients is a growing and challenging problem that is badly in need of additional therapies, particularly those that substantially prevent atrial fibrillation while also improving heart failure. Compared to the GENETIC-AF primary endpoint of time to first AF event, the reduction in AF burden measured by continuous device monitoring in a subgroup, increase in sinus rhythm measured by ECG in all patients and the reduction in AF interventions gives a much more comprehensive evaluation of the relative efficacy of bucindolol vs. metoprolol.”
Gencaro showed favorable treatment outcomes.
ARCA CEO Michael Bristow said, “AF burden is increasingly being recognized as a more sensitive measure of arrhythmia that is closely linked to key clinical outcomes. In the GENETIC-AF Phase 2b clinical trial device substudy and in the entire trial cohort, Gencaro demonstrated favorable treatment effects compared to the comparator arm.”