Zacks Small Cap Research – CVKD: Cadrenal Therapeutics and Abbott Collaborate on Novel Anticoagulant for LVAD Patients – Technologist

NASDAQ:CVKD

Cadrenal Therapeutics, Inc. (NASDAQ:CVKD), a biopharmaceutical company developing tecarfarin, has announced a collaborative effort with Abbott (NYSE:ABT) to advance this novel anticoagulant for patients with left ventricular assist devices (LVADs). This partnership aims to improve anticoagulation therapy for individuals with implanted cardiac devices, addressing an important unmet need in cardiovascular care.

Cadrenal Therapeutics is focused on developing tecarfarin, a late-stage novel oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients with certain rare cardiovascular conditions. Tecarfarin is a next-generation Vitamin K Antagonist (VKA) specifically designed to leverage a different metabolism pathway than warfarin, the oldest and most commonly prescribed VKA.

The drug has received multiple FDA designations, including Orphan Drug and Fast Track designations for preventing systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib). In April 2024, tecarfarin also received FDA Orphan Drug Designation for preventing blood clots and strokes in patients with implanted mechanical circulatory support devices, including LVADs.

Tecarfarin has been evaluated in eleven human clinical trials involving more than 1,000 individuals. Phase 1, Phase 2, and Phase 2/3 clinical trials have generally shown tecarfarin to be well-tolerated in both healthy adult subjects and patients with chronic kidney disease. These studies suggest that tecarfarin may provide improved anticoagulation quality, particularly in patients on multiple medications and those with impaired renal function – both common scenarios in LVAD patients.

All LVAD patients require lifelong anticoagulation to protect against thromboembolic events. Currently, the only LVAD available in the United States is Abbott’s HeartMate 3™, which has demonstrated superiority to previous LVAD models. A recent secondary analysis of Abbott’s ARIES-HM3 study highlighted the importance of high-quality anticoagulation in improving outcomes for HeartMate 3 LVAD patients.

The collaboration between Cadrenal Therapeutics and Abbott focuses on Cadrenal’s planned pivotal study of tecarfarin in patients with recently implanted LVADs. This study aims to further evaluate the efficacy and safety of tecarfarin in this specific patient population.

While the companies express optimism about tecarfarin’s potential, further clinical studies are needed to confirm its efficacy and safety in LVAD patients. As with all drug development programs, there are inherent risks and uncertainties that could impact the ultimate success of tecarfarin in this indication.

Cadrenal Therapeutics is committed to bringing this novel therapy to the market to help improve the lives of thousands of individuals who suffer from rare cardiovascular conditions. The collaboration with Abbott highlights ongoing efforts in the medical community to improve anticoagulation strategies for patients with advanced heart failure requiring mechanical circulatory support. As the field continues to evolve, such partnerships may be crucial in advancing patient care and outcomes for those relying on LVADs and other mechanical circulatory support devices.

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