- The analysis highlights the growing need to evolve anticoagulation therapy beyond warfarin to prevent gastrointestinal bleeding, a significant and common complication in patients with left ventricular assist devices (LVADs) that leads to costly hospital stays.
- Tecarfarin, a novel vitamin K antagonist (VKA), uses a different metabolic pathway than warfarin, the most commonly used anticoagulant for LVAD patients, and may provide more stable and effective anticoagulation
PONTE-VEDRA, Florida., 20 August 2024 /PRNewswire/ — Cadrenal Therapeutics, Inc.(Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a next-generation VKA, an oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes and deaths due to blood clots in patients with implanted cardiac devices or rare cardiovascular diseases, today presented a manuscript, recently peer-reviewed and published in the Journal of Cardiac Failure, examining the relationship between time in therapeutic range (TTR), quality of care and clinical outcomes in LVAD patients. These findings focus on the potential role of investigating new VKA agents beyond warfarin in improving clinical outcomes in LVAD patients.
In the manuscript, which was co-authored by Mandeep R. MehraMD, MSc, FRCP, Brigham and Women’s Hospital Heart and Vascular Center, Center for Advanced Heart Disease, titled “Antithrombotic Strategies Using Left Ventricular Devices,” concludes that while the current generation of LVAD pumps has largely overcome the adverse effects associated with hemocompatibility, anticoagulant therapy must continue to evolve to prevent persistent gastrointestinal bleeding that leads to frequent hospitalizations, procedures, blood transfusions, decreased quality of life, and increased costs of care.1
Dr. Mandeep Mehra, who led the ARIES-HM3 trial, commented: “Tecarfarin could potentially be an important therapy for patients with LVADs, all of whom require chronic anticoagulation, as unlike warfarin, it is not affected by drug interactions or changes in renal function and deserves further study.”
A secondary analysis of the ARIES-HM3 trial sponsored by Abbott examined the relationship between quality of VKA treatment and clinical outcomes, achieving a median TTR for VKA of 56%. This analysis found an inverse relationship between TTR and bleeding events, with bleeding risk reduced by 47% in patients with a TTR above the median. Lower TTRs were associated with three times more subtherapeutic INRs than supratherapeutic INRs, with no clear association between higher INRs and bleeding events.
“These results reinforce our confidence that tecarfarin has the potential to more effectively address the critical unmet anticoagulation needs of LVAD patients,” said Quang X. Pham, Chairman and Chief Executive Officer of Cadrenal Therapeutics. “We look forward to working with the LVAD community to potentially bring our next-generation VKA to patients.”
About Tecarfarin
Tecarfarin is the only oral anticoagulant being developed worldwide for patients with implanted cardiac devices and other rare cardiovascular diseases. It is specifically designed to overcome many of the problems experienced by patients with warfarin. Tecarfarin is metabolized via carboxylesterase rather than the cytochrome P450 system, allowing the drug to avoid interactions with many other commonly used medications and potentially provide more stable anticoagulation, even in patients with renal impairment, which is common in LVAD patients. In a Phase II study of 66 patients with atrial fibrillation who were switched from warfarin to tecarfarin, the mean interpolated TTR within three weeks was 71.4%, with minimal time spent in extreme INR ranges (4.0). If approved, tecarfarin has the potential to be the only approved drug for LVAD patients in the U.S.
In addition, tecarfarin may prove useful for other patients in whom warfarin does not provide the recommended anticoagulation due to genetic warfarin resistance or renal insufficiency that makes warfarin metabolism difficult. These include people with end-stage renal failure and atrial fibrillation, or those with mechanical heart valves and a difficult-to-control international normalized ratio, which indicates how long it takes for blood to clot.
To 6 August 2024Cadrenal Therapeutics announced that it has been in discussions with Abbott about Cadrenal’s planned pivotal study of tecarfarin in patients with recently implanted LVADs. LVAD patients require lifelong anticoagulation to protect against thromboembolic events. The only LVAD available in the U.S. is Abbott’s HeartMate 3TM.
On April 9, 2024, Cadrenal Therapeutics announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation to tecarfarin for the prevention of thromboembolism and thrombosis in patients with an implanted mechanical circulatory support device, which includes the LVAD.
About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics is developing tecarfarin to address unmet needs in anticoagulation therapy. Tecarfarin is a novel oral and reversible anticoagulant (blood thinner) in late-stage development for the prevention of heart attacks, strokes and deaths from blood clots in patients with implanted cardiac devices and patients with rare cardiovascular diseases. Tecarfarin has Orphan Drug designation for the prevention of thrombosis and thromboembolism in patients with ventricular assist devices (VADs). Tecarfarin also has FDA Orphan Drug and Fast Track designation for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage renal failure and atrial fibrillation. Cadrenal is also pursuing additional regulatory strategies to address unmet needs in anticoagulation therapy for patients with thrombotic antiphospholipid syndrome. Tecarfarin is specifically designed to use a different metabolic pathway than the oldest and most commonly prescribed vitamin K antagonist (warfarin). Tecarfarin has been tested in 11 human clinical trials involving more than 1,000 people. In Phase 1, Phase 2, and Phase 2/3 clinical trials, tecarfarin was generally well tolerated by both healthy adults and patients with chronic kidney disease. For more information, visit: www.cadrenal.com.
Safe Harbor Statement
All statements contained in this press release regarding future expectations, plans and prospects and all other statements regarding matters that are not historical facts may constitute “forward-looking statements.” These statements include statements that tecarfarin provides more stable and effective anticoagulation than warfarin, that research into new VKA agents beyond warfarin may help improve clinical outcomes in LVAD patients, that anticoagulant therapy must continue to evolve to prevent persistent gastrointestinal bleeding, that tecarfarin may be an important therapy for patients with LVADs who all require chronic anticoagulation because it is not affected by drug interactions or changes in renal function like warfarin, that tecarfarin has the potential to more effectively meet the critical unmet anticoagulation needs of LVAD patients, and that it may bring the Company’s next generation VKA to patients. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “seek,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated in such forward-looking statements as a result of various important factors, including the ability of tecarfarin to improve anticoagulation treatment in patients, the Company’s ability to further develop tecarfarin in patients with left ventricular assist devices (LVADs) and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017. December 31, 2023and the Company’s subsequent filings with the SEC, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. All forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
For further information please contact:
Cadrenal Therapeutics:
Matthew SzotChief Financial Officer
858-337-0766
(email protected)
Investors:
Lytham Partners, LLC
Robert BlumManaging Partner
602-889-9700
(email protected)
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