ARCA Biopharma files provisional patent application after GENETIC-AF findings
ARCA Biopharma announced it recently filed a provisional patent application with the United States Patent and Trademark Office, or USPTO, covering Gencaro's potential treatment effect in preventing atrial fibrillation, or AF, in patients with heart failure, or HF. The patent application is based on recent findings from the GENETIC-AF Phase 2B study of Gencaro, The new discoveries from the GENETIC-AF study that are covered by the patent application include the 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, or LVEF, with greater treatment effects correlating directly with increasing LVEF; and with the strongest treatment effects observed in study populations with the highest LVEF. ARCA believes this clinical data may be explained by both Gencaro's mechanism of action in its drug class, as well as by factors related to the pharmacotherapy of AF intersecting with HF. 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 of 40%, which includes HF patients with mid-range ejection fraction and HF patients with preserved ejection fraction, which represent more than half of all heart failure. ARCA expects to file the provisional application internationally and seek patent protection in the major pharmaceutical markets including the United States, European Union, Canada, Japan and China.