Patients with ESKD 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.
The Problem
There are currently no effective anticoagulation treatment options for patients with ESKD and AFib.
Commonly prescribed medications, such as warfarin and apixaban (Eliquis), 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 ESKD + AFib.
Prevalence
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 ESKD, with approximately 70% on dialysis. Approximately 150,000 ESKD patients also have AFib.
AFib nearly doubles the anticipated mortality and increases the stroke risk by approximately five-fold in these patients.
Our Solution
Our lead drug candidate, tecarfarin, targets a different metabolic pathway than the most commonly prescribed drugs for the treatment of ESKD 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 1,000 individuals. In Phase 1, Phase 2 and Phase 2/3 clinical trials that have been conducted thus far, tecarfarin has generally been well-tolerated in both healthy adult patients and patients with chronic kidney disease.
