Cadrenal Therapeutics is a biopharmaceutical company developing a late-stage novel therapy with orphan drug indication, tecarfarin, for the prevention of systemic thromboembolism, more commonly referred to as blood clots, of cardiac origin in patients with end-stage renal disease and atrial fibrillation (ESRD + AFib). Tecarfarin is a Phase 3-ready, Vitamin K antagonist (VKA) taken once a day as an oral anticoagulant, similar to warfarin. Tecarfarin is designed to have the same well-established and reversible VKA mechanism of action as warfarin, but to be free of certain potentially life-threatening drug clearance and drug-to-drug interaction problems associated with warfarin, particularly in patients with end-stage renal disease (ESRD). 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 been conducted thus far, tecarfarin has generally been well-tolerated in both healthy adult patients and patients with chronic kidney disease (CKD). These prior studies provide evidence to indicate that tecarfarin has the potential to treat patients with ESRD + AFib. While warfarin is indicated in these patients, it is not used consistently due to safety concerns. The alternate metabolism of tecarfarin is designed to reduce the safety concerns resulting from warfarin’s metabolism and drug-drug interactions. Lee’s Pharmaceutical Holdings Limited, our overseas partner, is developing tecarfarin as an anti-thrombotic for patients with mechanical heart valves (MHV). In 2020 and 2021, Lee’s Pharm completed two Phase 1 studies in China and Hong Kong and is currently preparing for its Phase 2 trial.
