AF is considered an epidemic cardiovascular disease with an estimated prevalence of at least 2.7 million Americans in 2010. In HFREF patients, the approved therapies for the treatment or prevention of AF have disadvantages, such as toxic or cardiovascular adverse effects, and most of the approved drugs are contra-indicated or have warnings in their prescribing information. ARCA believes there is an unmet medical need for new AF treatments that are safe and more effective in the HFREF population at risk for AF.
ARCA has received guidance from the Food and Drug administration (“FDA”) regarding a Phase 3 clinical study comparing Gencaro to metoprolol for the prevention of AF in approximately 600 HFREF patients, with a design similar to GENETIC-AF, but without an adaptive feature. Based on this FDA guidance, the Company believes that a successful Phase 3 clinical study similar to GENETIC-AF, with a p-value of less than 0.01, could be sufficient evidence of efficacy upon which to base a New Drug Application (“NDA”) for the approval of Gencaro for an AF indication in HFREF patients. ARCA plans to obtain further guidance from the FDA, which may affect the trial’s design.
The proposed collaboration with Medtronic involves a substudy of the Phase 2B portion of GENETIC-AF that will measure the AF burden data by means of the continuous monitoring devices. Under the proposed collaboration, Medtronic would provide support associated with the AF burden substudy and with collection and analysis of the substudy data.
Dr. Michael Bristow, MD, PhD., President and Chief Executive Officer of ARCA, said, “We at ARCA are excited about the new adaptive design for GENETIC-AF and the potential to use AF burden measured by previously implanted devices as well as by newly inserted implantable loop recorders, which we believe represent the next generation of diagnosis and treatment options for patients at risk for AF. AF is a serious disorder that increases the risk of stroke and mortality, and in HFREF patients often heralds the worsening of heart failure. There is a need for new treatment options, particularly for patients with HFREF. The GENETIC-AF trial has the potential to result in an approvable new therapy that is safe and effective for HFREF patients at high risk for AF. We believe that the use of continuous monitoring devices including implantable loop recorders to monitor AF burden in the Phase 2B substudy will result in many more clinically-relevant events, which will potentially increase the power and usefulness of the data. We believe that AF burden used in conjunction with drug therapy will become an increasingly important tool in the diagnosis and treatment of AF.”