- Analysis in full patient cohort shows Gencaro effect compared to standard of care
- In the GENETIC-AF entire cohort of heart failure patients treated with Gencaro, compared to patients treated with metoprolol succinate (TOPROL-XL), experienced:
- a 36% reduction in cumulative atrial fibrillation burden with a 55% reduction in daily atrial fibrillation burden by the end of the study
- a 32% reduction in the rate of rhythm control clinical interventions, and
- a 39% increase in electrocardiograms demonstrating normal sinus rhythm
- Aspects of these data are the basis for the new patent issued by USPTO for use of Gencaro in treating atrial fibrillation in heart failure patients with ejection fractions greater than 40%, a patient population for whom there are few approved or effective drug therapies
In the trial, the prevalence of electrocardiograms (ECGs) in normal sinus rhythm, AF interventions for rhythm control (electrical cardioversion, catheter ablation and Class III antiarrhythmic drugs), and biomarkers were evaluated in the overall population entering efficacy follow-up (N=257). AF burden was evaluated for 24 weeks in a device substudy (N=67) in which all patients had continuous monitoring of cardiac rhythm by implanted devices.
In 257 patients with HF, the mean age was 65.6 ± 10.0 years, 18% were female, mean left ventricular ejection fraction (LVEF) was 36%, and 51% had persistent AF. Cumulative 24-week AF burden was 24.4% (95% CI: 18.5, 30.2) for bucindolol and 36.7% (95% CI: 30.0, 43.5) for metoprolol (36% reduction, p =0.002). Daily AF burden at the end of follow-up was 15.1% (95% CI: 3.2, 27.0) for bucindolol and 34.7% (95% CI: 17.9, 51.2) for metoprolol (55% reduction, p < 0.001). The prevalence of ECGs in normal sinus rhythm was 4.20 and 3.03 events per patient for the bucindolol and metoprolol groups, respectively (39% increase, p < 0.001); whereas the rate of AF rhythm control interventions was 0.56 and 0.82 events per patient for the bucindolol and metoprolol groups, respectively (32% reduction, p = 0.011). Reductions in plasma norepinephrine (p = 0.038) and NT-proBNP (p = 0.009) were observed with bucindolol compared to metoprolol.
An additional analysis of these new data confined to patients with ejection fractions of 40% and above showed novel evidence of a clinically significant potential treatment effect for Gencaro in preventing and treating atrial fibrillation in these patients. Patients with this classification of heart failure, known as mildly reduced (HFmrEF) blending into preserved left ventricular ejection fraction (HFpEF) HF, have few approved or effective drug therapies. This novel result provided the basis for a new patent issued to ARCA by the United States Patent and Trademark Office (USPTO) in
Dr.
About ARCA biopharma
ARCA biopharma is dedicated to developing genetically targeted therapies for cardiovascular diseases through a precision medicine approach to drug development. ARCA is developing rNAPc2 as a potential treatment for diseases caused by RNA viruses, initially focusing on COVID-19. The
Safe Harbor Statement
This press release contains "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the potential future development plans for Gencaro and rNAPc2, the expected features and characteristics of Gencaro and rNAPc2, including the potential for genetic variations to predict individual patient response to Gencaro, Gencaro’s potential to treat atrial fibrillation, rNAPc2’s potential to treat COVID-19, future treatment options for patients with COVID-19 or AF, and the potential for Gencaro to be the first genetically targeted AF prevention treatment. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: ARCA’s financial resources and whether they will be sufficient to meet its business objectives and operational requirements; ARCA may not be able to raise sufficient capital on acceptable terms, or at all, to continue development of rNAPc2 or Gencaro or to otherwise continue operations in the future; results of earlier clinical trials may not be confirmed in future trials; the protection and market exclusivity provided by ARCA’s intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. These and other factors are identified and described in more detail in ARCA’s filings with the
Investor & Media Contact:
720.940.2163
derek.cole@arcabio.com
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Dr. Bristow
Dr. Michael Bristow , President and CEO, ARCA biopharma, Inc.
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