Cadrenal Therapeutics Highlights Publication of Peer-Reviewed Article Supporting Need for New Anticoagulation Therapy for Patients with Certain Medical Conditions
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Insights
From a cardiology perspective, the recent peer-reviewed article referenced by Cadrenal Therapeutics underscores critical considerations in the management of anticoagulation therapy. Anticoagulants are a cornerstone in the treatment of atrial fibrillation and venous thromboembolism, conditions with high morbidity and mortality rates. The efficacy of direct oral anticoagulants (DOACs) has been well-documented; however, their limitations in certain patient populations, such as those with mechanical heart valves, thrombotic antiphospholipid syndrome (APS) and end-stage kidney disease (ESKD), are noteworthy.
Patients with these conditions are at an elevated risk of thrombotic events and the suboptimal performance of DOACs could lead to serious clinical consequences. The development of alternative anticoagulants like tecarfarin by Cadrenal Therapeutics could potentially fill the gap in these high-risk patient groups. The nuanced understanding of the pharmacological profile and patient-specific considerations is essential for improving clinical outcomes.
Considering the market dynamics, the anticoagulant sector is highly competitive with established players and blockbuster drugs like Eliquis and Xarelto. The emphasis on Cadrenal Therapeutics' tecarfarin suggests a strategic move to carve out a niche within this market for patients where DOACs are contraindicated or less effective. Given that the current standard of care, warfarin, has well-known limitations such as the need for regular monitoring and dietary restrictions, tecarfarin could represent a significant improvement if it can offer greater safety and efficacy without these drawbacks.
Investors and stakeholders should closely monitor Cadrenal's clinical trial progress and regulatory interactions as they will be pivotal in determining the drug's commercial potential. A successful entry into the market could disrupt the current anticoagulant landscape and provide substantial returns, but the path to FDA approval and market acceptance is fraught with challenges, including rigorous clinical trials and the need to demonstrate clear advantages over existing therapies.
The mention of the peer-reviewed article in the Journal of the American College of Cardiology (JACC) adds scientific credibility to the arguments presented by Cadrenal Therapeutics. The research community values such publications as they undergo rigorous scrutiny before publication. The highlighted deficiencies in current DOAC therapies, as identified in the article, provide a clear research and development direction for pharmaceutical companies like Cadrenal.
For stakeholders, the advancement of tecarfarin into later stages of clinical trials could signal a significant milestone. The drug's ability to address unmet medical needs in anticoagulation therapy not only has the potential to improve patient care but also to drive financial growth for the company. However, the long-term success of tecarfarin will depend on its clinical trial results, safety profile and efficacy in comparison to both DOACs and warfarin.
Consistent with the evolving evidence documenting the need for VKA-based anticoagulant therapy, while simultaneously recognizing the deficiencies of the available VKA anticoagulants (such as warfarin), this latest peer-reviewed journal publication highlights:
- For most patients, DOACs are preferred over existing Vitamin K Antagonists [warfarin] for stroke prevention in atrial fibrillation (AFib) and venous thromboembolism treatment.
- However, randomized controlled trials indicate that DOACs may not be as efficacious or as safe in conditions such as mechanical heart valves, thrombotic antiphospholipid syndrome (APS), and AFib associated with end-stage kidney disease (ESKD).
- Their [DOACs] efficacy is uncertain for conditions such as left ventricular thrombus, and for patients with AFib or venous thrombosis who have ESKD.
"This expert review provides an assessment of the available evidence regarding DOACs, detailing not only when they have demonstrated efficacy and safety, but also when the DOACs have failed and therefore should not be the standard of care," commented Quang Pham, Founder, Chairman and Chief Executive Officer of Cadrenal Therapeutics. "These critical gaps in anticoagulation therapy, such as for patients with left ventricular assist devices (LVADs), thrombotic APS, and those with AFib and ESKD, highlight and support the need for the advancement of our tecarfarin development program to serve these patients."
Further information on the article is available at https://www.jacc.org/doi/epdf/10.1016/j.jacc.2023.10.038.
ABOUT CADRENAL THERAPEUTICS, INC.
Cadrenal Therapeutics is developing tecarfarin for unmet needs in anticoagulation therapy. Tecarfarin is a late-stage novel oral and reversible anticoagulant (blood thinner) to prevent heart attacks, strokes, and deaths due to blood clots in patients with certain medical conditions. Tecarfarin has orphan drug and fast track designations from the FDA for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib). Cadrenal is also pursuing additional regulatory strategies for unmet needs in anticoagulation therapy for patients with left ventricular assist devices (LVADs) and those with thrombotic antiphospholipid syndrome (APS). Tecarfarin is specifically designed to leverage a different metabolism pathway than the oldest and most commonly prescribed Vitamin K Antagonist (warfarin). Tecarfarin has been evaluated in eleven (11) human clinical trials and more than 1,000 individuals. In Phase 1, Phase 2, and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease. For more information, please visit: www.cadrenal.com.
Safe Harbor Statement
Any statements contained in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements." These statements include statements regarding the critical gaps in anticoagulation therapy, such as for patients with left ventricular assist devices (LVADs), thrombotic APS, and those with AFib and ESKD, highlighting and supporting the need for the advancement of our tecarfarin development program to serve these patients.The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "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 by such forward-looking statements as a result of various important factors, including the ability to advance tecarfarin with patients with left ventricular assist devices (LVADs), thrombotic APS, and those with AFib and ESKD and the other risk factors described in the Company's Annual Report on Form 10-K for the year ended December 31, 2022, and 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. Any 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 specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.
For more information, please contact:
Cadrenal Therapeutics:
Matthew Szot, CFO
858-337-0766
press@cadrenal.com
Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com
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SOURCE Cadrenal Therapeutics, Inc.
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