CADRENAL THERAPEUTICS HIGHLIGHTS PRESENTATION AT EUROPEAN ASSOCIATION FOR CARDIO-THORACIC SURGERY (EACTS) MEDICAL CONGRESS
Cadrenal Therapeutics (CVKD) highlighted a presentation at the EACTS Medical Congress featuring tecarfarin data and their proposed clinical trial protocol. The presentation, titled Tecarfarin and Hemocompatibility with LVAD Therapy (TECH-LVAD), focused on evaluating tecarfarin versus warfarin in patients with Abbott HeartMate3 left ventricular assist device. Dr. Mandeep R. Mehra presented data showing the relationship between bleeding rates and time in therapeutic range for HM3 patients, and evidence of tecarfarin's potential to improve TTR. The presentation also highlighted that end-stage kidney disease doesn't alter tecarfarin exposure, unlike warfarin, which is significant as many LVAD patients have kidney impairment.
Cadrenal Therapeutics (CVKD) ha evidenziato una presentazione al Congresso Medico EACTS che ha presentato i dati su tecarfarin e il loro protocollo di prova clinica proposto. La presentazione, intitolata Tecarfarin e Emocompatibilità con la Terapia LVAD (TECH-LVAD), si è concentrata sulla valutazione di tecarfarin rispetto a warfarin nei pazienti con dispositivo di assistenza ventricolare sinistra Abbott HeartMate3. Il Dr. Mandeep R. Mehra ha presentato dati che mostrano la relazione tra i tassi di sanguinamento e il tempo nell'intervallo terapeutico per i pazienti HM3, e le evidenze del potenziale di tecarfarin per migliorare il TTR. La presentazione ha anche sottolineato che la malattia renale terminale non altera l'esposizione a tecarfarin, a differenza di warfarin, il che è significativo poiché molti pazienti LVAD presentano deterioramento renale.
Cadrenal Therapeutics (CVKD) destacó una presentación en el Congreso Médico EACTS con datos de tecarfarin y su protocolo de ensayo clínico propuesto. La presentación, titulada Tecarfarin y Hemocompatibilidad con la Terapia LVAD (TECH-LVAD), se centró en evaluar tecarfarin frente a warfarin en pacientes con el dispositivo de asistencia ventricular izquierda Abbott HeartMate3. El Dr. Mandeep R. Mehra presentó datos que muestran la relación entre las tasas de sangrado y el tiempo en el rango terapéutico para los pacientes HM3, y evidencia del potencial de tecarfarin para mejorar el TTR. La presentación también destacó que la enfermedad renal en etapa terminal no altera la exposición a tecarfarin, a diferencia de warfarin, lo cual es significativo ya que muchos pacientes LVAD tienen deterioro renal.
Cadrenal Therapeutics (CVKD)는 EACTS 의료 congress에서 tecarfarin 데이터와 제안된 임상 시험 프로토콜을 강조하는 발표를 진행했습니다. 테카르파린 및 LVAD 요법과의 혈액 호환성 (TECH-LVAD)라는 제목의 이 발표에서는 Abbott HeartMate3 좌심실 보조장치 환자를 위한 테카르파린과 와파린을 평가하는 데 초점을 맞췄습니다. Mandeep R. Mehra 박사는 HM3 환자의 출혈률과 치료 범위 유지 시간 간의 관계를 보여주는 데이터를 제시했으며, tecarfarin이 치료 범위를 개선할 가능성에 대한 증거를 제공했습니다. 발표는 또한 말기 신장 질환이 tecarfarin의 노출을 변화시키지 않는 반면, 와파린은 영향을 미친다는 점을 강조했습니다. 이는 많은 LVAD 환자가 신장 기능 저하를 겪고 있다는 점에서 중요합니다.
Cadrenal Therapeutics (CVKD) a souligné une présentation lors du Congrès Médical EACTS mettant en avant les données de tecarfarin et leur protocole d'essai clinique proposé. La présentation, intitulée Tecarfarin et Hémocompatibilité avec la Thérapie LVAD (TECH-LVAD), a mis l'accent sur l'évaluation de tecarfarin par rapport à warfarin chez les patients avec dispositif d'assistance ventriculaire gauche Abbott HeartMate3. Le Dr. Mandeep R. Mehra a présenté des données montrant la relation entre les taux de saignement et le temps dans la plage thérapeutique pour les patients HM3, ainsi que des éléments probants du potentiel de tecarfarin à améliorer le TTR. La présentation a également souligné que la maladie rénale terminale n'altère pas l'exposition à tecarfarin, contrairement à warfarin, ce qui est significatif puisque de nombreux patients LVAD présentent une insuffisance rénale.
Cadrenal Therapeutics (CVKD) hat eine Präsentation auf dem EACTS Medizinischen Kongress hervorgehoben, die Daten zu tecarfarin und dem vorgeschlagenen klinischen Prüfprotokoll enthielt. Die Präsentation mit dem Titel Tecarfarin und Hämo-kompatibilität mit LVAD-Therapie (TECH-LVAD) konzentrierte sich auf die Bewertung von tecarfarin im Vergleich zu warfarin bei Patienten mit dem Abbott HeartMate3 linken Ventrikelunterstützungssystem. Dr. Mandeep R. Mehra präsentierte Daten, die die Beziehung zwischen Blutungsraten und der Zeit im therapeutischen Bereich für HM3-Patienten zeigen, sowie Belege für das Potenzial von tecarfarin zur Verbesserung des TTR. Die Präsentation hob auch hervor, dass eine terminale Nierenerkrankung die Exposition gegenüber tecarfarin nicht verändert, im Gegensatz zu warfarin, was signifikant ist, da viele LVAD-Patienten unter Nierenbeeinträchtigung leiden.
- Tecarfarin shows potential advantages over warfarin in LVAD patients with kidney impairment
- Company progressing discussions with FDA and Abbott for tecarfarin study
- None.
Insights
The presentation of tecarfarin data at EACTS represents an incremental development in Cadrenal's clinical program, but lacks significant immediate impact. While the historical data and proposed trial protocol for TECH-LVAD show promise, particularly regarding tecarfarin's potential advantages in LVAD patients with kidney impairment, this is primarily a scientific communication event without material business implications.
The key differentiator highlighted - tecarfarin's consistent exposure in ESKD patients compared to warfarin's variable exposure - is scientifically interesting but requires validation through the proposed clinical trial. The company's discussions with the FDA and Abbott about the study protocol are still ongoing, indicating a lengthy path ahead before any potential commercialization.
Leading heart failure specialist features tecarfarin data and Cadrenal's proposed clinical trial protocol at 8th EACTS Mechanical Circulatory Support Summit
The presentation, titled Tecarfarin and Hemocompatibility with LVAD Therapy (TECH-LVAD), took place in
Dr. Mehra, who also chaired Abbott's ARIES-HM3 study in LVAD patients and is a Professor of Medicine, Harvard University, commented, "In the proposed TECH-LVAD trial, we plan to study a much-needed VKA option with the expectation of reducing bleeding events that accompany use of the HM3 LVAD in advanced heart failure. Tecarfarin could potentially be an important therapy for patients with LVADs who all require chronic anticoagulation."
"As our team progresses discussions with the FDA and Abbott about a tecarfarin study in LVAD patients, increasing tecarfarin data visibility will help us to continue accelerating our development as we plan for investigator outreach and patient recruitment for our tecarfarin trial," said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics.
ABOUT CADRENAL THERAPEUTICS, INC.
Cadrenal Therapeutics is a late-stage biopharmaceutical company developing tecarfarin, a new vitamin K antagonist (VKA) designed to offer safer, more effective chronic anticoagulation for patients with implanted cardiac devices or rare cardiovascular conditions. Tecarfarin is anticipated to result in fewer adverse events such as strokes, heart attacks, bleeds, and deaths than warfarin, the most commonly used anticoagulant for these patients, despite its prevalent adverse events, drug-to-drug interactions, and frequent dosing changes. Cadrenal is focused on evaluating tecarfarin's superiority to warfarin in these patients where direct oral anticoagulants (DOACs) are not recommended in the treatment guidelines of leading cardiology associations. Tecarfarin received an orphan drug designation for advanced heart failure patients with implanted left ventricular assist devices (LVADs) as well as both orphan drug and fast-track status for end-stage kidney disease patients with atrial fibrillation. Cadrenal is opportunistically planning pivotal clinical trials and pursuing clinical and commercial partnerships to advance tecarfarin. The company's plans also include studying tecarfarin in patients with mechanical heart valves experiencing anticoagulation difficulties. Visit www.cadrenal.com to learn more.
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 our planned pivotal trial to evaluate tecarfarin's effectiveness for LVAD patients, tecarfarin's potential ability to improve TTR; the plan to study a much-needed VKA option with the expectation to reduce bleeding events that accompany use of the HM3 LVAD in advanced heart failure; tecarfarin potentially being an important therapy for patients with LVADs who all require chronic anticoagulation and advancing the visibility of tecarfarin data helping to continue to accelerate the Company's development as it plans for investigator outreach and patient recruitment for its tecarfarin trial. 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 TTR and anticoagulation treatment in patients, the ability of the Company to advance tecarfarin with patients with left ventricular assist devices (LVADs) and those with ESKD with AFib, the collaborative efforts 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 Securities and Exchange Commission, 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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