Patients with end-stage renal disease and AFib represent a spectrum of disorders involving both the heart and kidneys (known as cardiorenal syndrome or CRS) in which acute or chronic dysfunction in one organ may induce acute or chronic dysfunction in the other organ.
There are currently no effective treatment options for patients with end-stage renal disease and AFib.
Commonly prescribed treatments, such as warfarin and apixaban, may cause substantial harm, leading to outcomes such as stroke, systemic embolism, major bleeding, or death. Yet most trials of anticoagulant therapy to reduce the risk of such events have excluded these patients.
These patients have typically been excluded from randomized clinical trials because approved therapies for AFib have metabolic profiles that may increase drug exposures in patients thereby increasing known risks and challenges in managing patients with ESRD + AFib.
AFib is the most common arrhythmia, with its incidence and prevalence increasing over the last 20 years.
There are more than 809,000 Americans with ESRD, with approximately 70% on dialysis. Approximately 150,000 ESRD patients also have AFib.
AFib nearly doubles the anticipated mortality and increases the stroke risk by approximately five-fold in these patients.
Our lead drug candidate, tecarfarin, targets a different metabolic pathway than the most commonly prescribed drugs for the treatment of thrombosis and AFib in order to potentially eliminate specific side effects while maintaining or improving effectiveness.
Tecarfarin has been evaluated in 11 human clinical trials in over a thousand individuals. In Phase 1, Phase 2 and Phase 2/3 clinical trials that have conducted thus far, tecarfarin has generally been well-tolerated in both healthy adult patients and patients with ESRD and chronic kidney disease.