Elaine M Hylek

Cadrenal Therapeutics is a late-stage biopharmaceutical company developing tecarfarin, an oral therapeutic designed to be a superior and safer Vitamin K antagonist (VKA) anticoagulant for patients with implanted cardiac devices or rare cardiovascular (CV) conditions. Cadrenal strives to improve outcomes and reduce adverse events for these patients such as strokes, heart attacks, bleeds, and deaths. These patients also lack approved chronic anticoagulation options besides warfarin, well-known for its serious side effects and frequent drug-drug interactions, resulting in complicated treatment management. Cadrenal’s drug candidate, tecarfarin, is a new VKA anticoagulant with extensive clinical data showing it is potentially superior and safer than warfarin, resulting in fewer adverse events. Tecarfarin is metabolized via a different pathway than warfarin and data demonstrate that its efficacy is unaffected by common drug-drug interactions or kidney impairment, which are common in these patients. Phase 2/3 clinical trials show that tecarfarin may offer more stability and time in therapeutic range (TTR) that inversely correlates with major events. Tecarfarin received an orphan drug designation for advanced heart failure patients with left ventricular assist devices (LVADs) as well as both orphan drug and fast-track status for end-stage kidney disease (ESKD) patients with atrial fibrillation. Cadrenal is opportunistically pursuing pivotal clinical trials with LVAD patients along with clinical and commercial partnership opportunities to advance tecarfarin. The company’s plans also include studying patients with mechanical heart valves who experience anticoagulation difficulties because of genetic warfarin resistance, polypharmacy, or kidney impairment.