ARCA biopharma Submits Patent Application to US Patent and Trademark Office for Atrial Fibrillation

ARCA biopharma (NASDAQ:ABIO) has announced it has filed a provisional patent application with the US Patent and Trademark Office covering Gencaro’s treatment effect in preventing atrial fibrillation (AF) in patients with heart failure (HF).

As quoted in the press release:

The patent application is based on recent novel findings from the GENETIC-AF Phase 2B study of Gencaro, described in “GENETIC-AF: Bucindolol for the Maintenance of Sinus Rhythm in a Genotype-Defined Heart Failure Population,” published in JACC: Heart Failure, a journal of the American College of Cardiology. The new discoveries from the GENETIC-AF study that are covered by the patent application include the key findings that patients who developed AF and HF contemporaneously, and those who did not have long-standing AF and HF, experience a stronger treatment effect from Gencaro.  Another unexpected observation from the study that is covered by the patent application is the relationship between Gencaro’s treatment effect for preventing AF recurrence and left ventricular ejection fraction (LVEF), with greater treatment effects correlating directly with increasing LVEF; and with the strongest treatment effects observed in study populations with the highest LVEF (LVEF ≥ 45%; n = 57; hazard ratio = 0.39; p < 0.05).

ARCA believes this clinical data may be explained by both Gencaro’s unique mechanism of action in its drug class, as well as by factors related to the pharmacotherapy of AF intersecting with HF.  This clinical data will be important in guiding the planned Phase 3 development of Gencaro for the treatment of AF in patients with HF, particularly in patients with LVEF ≥ 40%.

ARCA believes that the findings from GENETIC-AF in the application merit a patent.  The Company believes drugs in the beta-blocker class have not been adequately studied in HF patients with LVEF ≥ 40%, which includes HF patients with mid-range ejection fraction (HFmrEF) and HF patients with preserved ejection fraction (HFpEF).  HFmrEF and HFpEF represent more than half of all heart failure and there are currently no therapies shown to be effective for the treatment AF in these patients.

Click here to read the full press release.