Cadrenal Therapeutics and Abbott Initiate Collaborative Effort to Advance Novel Anticoagulant Tecarfarin for Patients with LVADs
Cadrenal Therapeutics (Nasdaq: CVKD) has initiated discussions with Abbott (NYSE: ABT) regarding a planned pivotal study of tecarfarin in patients with recently implanted Left Ventricular Assist Devices (LVADs). Tecarfarin, a late-stage anticoagulant, received FDA Orphan Drug Designation in April 2024 for preventing blood clots and strokes in patients with implanted mechanical circulatory support devices. The collaboration focuses on improving anticoagulation treatment for HeartMate 3™ LVAD patients, currently the only LVAD available in the United States.
A recent analysis of the ARIES-HM3 study by Abbott highlighted that high-quality anticoagulation can further enhance outcomes with the HeartMate 3 LVAD. Prior clinical studies suggest that tecarfarin may provide improved anticoagulation quality, particularly in patients on multiple medications or with impaired renal function, both common in LVAD patients.
Cadrenal Therapeutics (Nasdaq: CVKD) ha avviato discussioni con Abbott (NYSE: ABT) riguardo a uno studio pivotale programmato su tecarfarin in pazienti con dispositivi di assistenza ventricolare sinistra (LVAD) recentemente impiantati. Tecarfarin, un anticoagulante in fase avanzata, ha ricevuto la designazione di farmaco orfano dalla FDA nell'aprile 2024 per la prevenzione di coaguli di sangue e ictus in pazienti con dispositivi di supporto circolatorio meccanico impiantati. La collaborazione si concentra sul miglioramento del trattamento anticoagulante per i pazienti con LVAD HeartMate 3™, attualmente l'unico LVAD disponibile negli Stati Uniti.
Un'analisi recente dello studio ARIES-HM3 condotta da Abbott ha evidenziato che un'adeguata anticoagulazione può ulteriormente migliorare i risultati con il LVAD HeartMate 3. Studi clinici precedenti suggeriscono che tecarfarin potrebbe fornire una migliore qualità dell'anticoagulazione, in particolare in pazienti in terapia con più farmaci o con funzione renale compromessa, condizioni comuni nei pazienti con LVAD.
Cadrenal Therapeutics (Nasdaq: CVKD) ha iniciado conversaciones con Abbott (NYSE: ABT) sobre un estudio pivotal planificado de tecarfarina en pacientes con Dispositivos de Asistencia Ventricular Izquierda (LVAD) recién implantados. Tecarfarina, un anticoagulante en etapas avanzadas, recibió la designación de medicamento huérfano por parte de la FDA en abril de 2024 para prevenir coágulos sanguíneos e ictus en pacientes con dispositivos de soporte circulatorio mecánico implantados. La colaboración se centra en mejorar el tratamiento anticoagulante para pacientes con LVAD HeartMate 3™, que actualmente es el único LVAD disponible en los Estados Unidos.
Un análisis reciente del estudio ARIES-HM3 realizado por Abbott destacó que una anticoagulación de alta calidad puede mejorar aún más los resultados con el LVAD HeartMate 3. Estudios clínicos anteriores sugieren que la tecarfarina podría proporcionar una mejor calidad de anticoagulación, especialmente en pacientes que están en múltiples medicamentos o con función renal comprometida, condiciones que son comunes en pacientes con LVAD.
Cadrenal Therapeutics (Nasdaq: CVKD)가 HeartMate 3™ 좌심실 보조 장치(LVAD)를 최근 이식받은 환자를 대상으로 하는 계획된 주요 연구에 대해 Abbott(NYSE: ABT)와 논의에 착수했습니다. Tecarfarin은 최종 단계의 항응고제로, 2024년 4월 FDA에서 기계적 순환 보조 장치가 이식된 환자에서 혈전 및 뇌졸중 예방을 위한 희귀약품으로 지정되었습니다. 이 협력은 현재 미국에서 유일하게 사용 가능한 LVAD인 HeartMate 3™ 환자들을 위한 항응고 치료 개선에 중점을 두고 있습니다.
Abbott가 진행한 ARIES-HM3 연구의 최근 분석에 따르면 고품질의 항응고 치료가 HeartMate 3 LVAD의 결과를 더욱 향상시킬 수 있다는 점이 강조되었습니다. 이전의 임상 연구들은 tecarfarin이 여러 약물을 복용하거나 신장 기능이 저하된 환자들에게 항응고 품질을 개선할 수 있을 것이라고 제안합니다. 이는 LVAD 환자에게서 흔히 나타나는 상황입니다.
Cadrenal Therapeutics (Nasdaq: CVKD) a engagé des discussions avec Abbott (NYSE: ABT) concernant une étude pivot prévue sur tecarfarin chez des patients ayant récemment reçu des dispositifs d'assistance ventriculaire gauche (LVAD). Tecarfarin, un anticoagulant en phase avancée, a reçu la désignation de médicament orphelin par la FDA en avril 2024 pour prévenir les caillots sanguins et les AVC chez les patients disposant de dispositifs de soutien circulatoire mécanique implantés. La collaboration vise à améliorer le traitement anticoagulant pour les patients avec LVAD HeartMate 3™, actuellement le seul LVAD disponible aux États-Unis.
Une analyse récente de l'étude ARIES-HM3 par Abbott a souligné qu'une anticoagulation de haute qualité peut encore améliorer les résultats avec le LVAD HeartMate 3. Des études cliniques antérieures suggèrent que tecarfarin pourrait offrir une meilleure qualité d'anticoagulation, en particulier chez les patients sous multiple médicaments ou ayant une fonction rénale altérée, deux situations courantes chez les patients recevant un LVAD.
Cadrenal Therapeutics (Nasdaq: CVKD) hat Gespräche mit Abbott (NYSE: ABT) über eine geplante entscheidende Studie zu tecarfarin bei Patienten mit neu implantierten linksventrikulären Unterstützungsgeräten (LVAD) initiiert. Tecarfarin, ein Antikoagulans in der fortgeschrittenen Phase, erhielt im April 2024 die Orphan-Drug-Bezeichnung der FDA zur Verhinderung von Blutgerinnseln und Schlaganfällen bei Patienten mit implantierten mechanischen Kreislaufstützgeräten. Die Zusammenarbeit konzentriert sich darauf, die Antikoagulationstherapie für Patienten mit HeartMate 3™ LVAD zu verbessern, das derzeit das einzige in den Vereinigten Staaten verfügbare LVAD ist.
Eine aktuelle Analyse der ARIES-HM3-Studie von Abbott hat hervorgehoben, dass eine hochwertige Antikoagulation die Ergebnisse mit dem HeartMate 3 LVAD weiter verbessern kann. Frühere klinische Studien deuten darauf hin, dass tecarfarin eine verbesserte Qualität der Antikoagulation bieten könnte, insbesondere bei Patienten, die mehrere Medikamente einnehmen oder eine eingeschränkte Nierenfunktion haben, was bei LVAD-Patienten häufig vorkommt.
- Collaboration with Abbott, a major medical device company, for tecarfarin study
- FDA Orphan Drug Designation received for tecarfarin in April 2024
- Potential to improve anticoagulation treatment for HeartMate 3 LVAD patients
- Prior clinical studies show tecarfarin's effectiveness in complex patient populations
- None.
This collaboration between Cadrenal Therapeutics and Abbott marks a significant development in anticoagulation therapy for LVAD patients. Tecarfarin, as a new-generation VKA, could potentially address the limitations of current anticoagulants used in this population.
The FDA Orphan Drug Designation for tecarfarin in LVAD patients underscores its potential importance. If successful, this could lead to improved outcomes and reduced complications for HeartMate 3 users, who currently rely on warfarin or other anticoagulants with known limitations.
The recent ARIES-HM3 study findings suggesting that high-quality anticoagulation can further improve HeartMate 3 outcomes aligns well with tecarfarin's potential benefits. However, it's important to await the results of the planned pivotal study to confirm tecarfarin's efficacy and safety profile in this specific patient population.
This collaboration represents a strategic move for both Cadrenal Therapeutics and Abbott. For Cadrenal, partnering with Abbott, the manufacturer of the only LVAD available in the US, provides significant credibility and potential market access. For Abbott, this collaboration could enhance the value proposition of their HeartMate 3 device by potentially improving patient outcomes.
The market potential for tecarfarin in LVAD patients is niche but valuable. With its Orphan Drug Designation, tecarfarin could enjoy market exclusivity if approved, providing a competitive advantage. However, investors should note that the drug is still in late-stage development and success is not guaranteed.
Financial implications are not yet clear, as terms of the collaboration were not disclosed. Investors should monitor for future updates on the pivotal study design, timeline and any financial arrangements between the companies.
PONTE VEDRA, Fla., Aug. 6, 2024 /PRNewswire/ -- Cadrenal Therapeutics, Inc., (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a late-stage, new-generation Vitamin K Antagonist (VKA) oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients with implanted cardiac devices and those with rare cardiovascular conditions, announced today that it has been in discussions with Abbott (NYSE: ABT) about Cadrenal's planned pivotal study of tecarfarin in patients with recently implanted LVADs. All patients with LVADs require lifelong anticoagulation (AC) to protect against thromboembolic events.
In April 2024, tecarfarin received FDA Orphan Drug Designation (ODD) to prevent blood clots and strokes in patients with implanted mechanical circulatory support devices such as LVADs.
Currently, the only LVAD available in
A recent secondary analysis of the ARIES-HM3 study conducted by Abbott on the necessity of aspirin therapy demonstrated that maintaining high-quality AC can result in further improvement of outcomes with the HeartMate 3 LVAD.
"We are pleased that Abbott has initiated a collaborative effort with us for this trial, which we believe is very important to LVAD patients," said Quang Pham, Chairman and Chief Executive of Cadrenal Therapeutics. "We believe that tecarfarin has the potential to further improve AC treatment for HeartMate 3 patients."
Prior clinical studies provide evidence that tecarfarin yields improved AC quality, particularly in patients on multiple medications and those with impaired renal function, both of which are common in LVAD patients.
ABOUT CADRENAL THERAPEUTICS, INC.
Cadrenal Therapeutics is developing tecarfarin for unmet needs in anticoagulation therapy. Tecarfarin is a new-generation Vitamin K Antagonist (VKA) oral and reversible anticoagulant (blood thinner) to prevent heart attacks, strokes, and deaths due to blood clots in patients with implanted cardiac devices and those with rare cardiovascular conditions. Tecarfarin has orphan drug designation from the FDA for the prevention of thrombosis and thromboembolism (blood clots) in patients with an implanted mechanical circulatory support device, which includes the left ventricular assist device (LVAD). Tecarfarin also has orphan drug and fast-track designations from the FDA for the prevention of systemic thromboembolism of cardiac origin in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib). Tecarfarin is specifically designed to use a different metabolism pathway than the oldest and most commonly prescribed VKA warfarin. Tecarfarin has been evaluated in eleven (11) human clinical trials in 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 Cadrenal's planned pivotal study of tecarfarin in patients with recently implanted LVADs, maintaining high-quality AC resulting in further improvement of outcomes with the HeartMate 3 LVAD, the collaborative effort with Abbott for the trial being very important to LVAD patients and tecarfarin having the potential to further improve AC treatment for HeartMate 3 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 of tecarfarin to improve outcomes in patients with a HeartMate 3, the ability of the Company to advance tecarfarin with patients with left ventricular assist devices (LVADs), and those with AFib and ESKD, the collaboration with Abbott being successful and the other risk factors described in the Company's Annual Report on Form 10-K for the year ended December 31, 2023, 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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