Cadrenal Therapeutics and Abbott Collaborate to Advance Tecarfarin for LVAD Patients

Cadrenal Therapeutics, Inc., a biopharmaceutical company listed on Nasdaq under the ticker CVKD, is focusing on developing tecarfarin, a new-generation Vitamin K Antagonist (VKA) that acts as an oral and reversible anticoagulant. Designed to prevent heart attacks, strokes, and deaths caused by blood clots, tecarfarin is particularly targeted at patients with implanted cardiac devices and those with rare cardiovascular conditions. As of August 6, 2024, Cadrenal announced its ongoing discussions with Abbott about conducting a pivotal study of tecarfarin in patients with recently implanted left ventricular assist devices (LVADs). These patients require lifelong anticoagulation to prevent thromboembolic events.

In April 2024, the FDA granted Orphan Drug Designation (ODD) to tecarfarin for preventing blood clots and strokes in patients with implanted mechanical circulatory support devices, including LVADs. The HeartMate 3™, manufactured by Abbott, is currently the only LVAD available in the U.S. and is noted for its superiority over previous models. A secondary analysis of Abbott's ARIES-HM3 study highlighted the necessity of aspirin therapy and showed that maintaining high-quality anticoagulation can improve outcomes for HeartMate 3 LVAD patients.

Quang Pham, Chairman and Chief Executive of Cadrenal Therapeutics, expressed satisfaction with the collaborative effort initiated by Abbott for this trial. Pham emphasized that tecarfarin has the potential to enhance anticoagulation treatment for HeartMate 3 patients. Prior clinical studies have indicated that tecarfarin improves the quality of anticoagulation, especially in patients taking multiple medications and those with impaired renal function—both common in LVAD patients.

Cadrenal Therapeutics, Inc. is committed to addressing unmet needs in anticoagulation therapy through the development of tecarfarin. Tecarfarin has been recognized with orphan drug designation by the FDA for preventing thrombosis and thromboembolism in patients with implanted mechanical circulatory support devices like LVADs. Additionally, tecarfarin has received orphan drug and fast-track designations from the FDA for preventing systemic thromboembolism of cardiac origin in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib).

Tecarfarin distinguishes itself by utilizing a different metabolic pathway compared to warfarin, the most commonly prescribed VKA. It has undergone extensive evaluation in eleven human clinical trials involving over 1,000 participants. These trials, including Phase 1, Phase 2, and Phase 2/3, have generally shown tecarfarin to be well-tolerated in both healthy adults and patients with chronic kidney disease.

Cadrenal Therapeutics continues to make strides in developing tecarfarin to meet the needs of patients requiring anticoagulation therapy, particularly those with complex cardiovascular conditions and implanted cardiac devices. The partnership and planned pivotal study with Abbott aim to further validate the benefits of tecarfarin, particularly for patients using the HeartMate 3 LVAD.