Cadrenal Therapeutics Announces Collaboration Agreement with Abbott to Advance Pivotal Study of Tecarfarin in Patients with HeartMate 3™ LVAD
The vitamin K antagonist (VKA) warfarin, commonly prescribed for patients with these conditions, is well known for its serious side effects and cumbersome treatment management.
Patients with implanted cardiac devices or rare cardiovascular conditions have been excluded from the late-stage trials for all direct oral anticoagulants, or DOACs (Eliquis-class drugs); subsequent trials have shown negative or inconclusive data for these patients.
Tecarfarin is metabolized via a different pathway than warfarin and data shows 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 that inversely correlates with major events.
Extensive data shows the potential of tecarfarin to be superior to warfarin, resulting in fewer adverse events such as strokes, heart attacks, bleeds and deaths for patients with implanted cardiac devices such as LVADs, MHVs or rare cardiovascular conditions such as ESKD with Afib.
Our Focus
We are developing tecarfarin, designed to be a superior and safer vitamin K antagonist (VKA), to elevate care for underserved patients needing chronic anticoagulation.
Our focus is on patients with implanted cardiac devices such as left ventricular assist devices (LVADs) or mechanical heart valves (MHVs) and individuals with end-stage kidney disease (ESKD) and plus atrial fibrillation (AFib).
Our mission is to build a company with product candidates that significantly improve quality of life and patient outcomes for individuals with rare cardiovascular conditions.
We are committed to bringing this novel therapy to the market to help improve the lives of the thousands of individuals who suffer from these medical conditions.
Clinical Trials
Tecarfarin has been evaluated in 11 human clinical trials in over 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.
Phase 2/3 clinical trials show that tecarfarin, compared to warfarin, may offer superior stability and time in therapeutic range that inversely correlates with major events.
We are currently preparing for a pivotal Phase 3 trial in LVAD patients.
Announces strategic clinical trial plans for tecarfarin in patients with End-Stage Kidney Disease (ESKD) transitioning to dialysis Tecarfarin can potentially address critical treatment gaps in patients with ESKD Pivotal step forward in pursuit of ESKD +
Advances knowledge about the use of tecarfarin in patients with severe kidney impairment, including dialysis Pivotal step forward in pursuit of ESKD + Atrial Fibrillation (AFib) registration trial Addresses a critical current treatment gap in patients
LVAD patients face a high risk of bleeding events associated with oral anticoagulation alongside increased risk of cardiovascular (CV) events such as stroke Hospitalization costs for patients following a major bleeding event associated with oral anticoagulation