Cadrenal Therapeutics Announces Upcoming Type-B FDA Meeting in September to Discuss Tecarfarin Trial in LVAD Patients
Cadrenal Therapeutics (Nasdaq: CVKD) has announced an upcoming Type-B FDA meeting in September to discuss the clinical trial for tecarfarin in LVAD patients. Tecarfarin is a late-stage, next-generation Vitamin K Antagonist (VKA) oral and reversible anticoagulant designed to prevent heart attacks, strokes, and deaths due to blood clots in patients with implanted cardiac devices and rare cardiovascular conditions.
The company aims to address unmet needs in anticoagulation therapy, particularly for LVAD patients who face an increased risk of thromboembolic events. Tecarfarin has received orphan drug designation for thrombosis prevention in patients with ventricular assist devices, as well as orphan drug and fast-track designations for preventing systemic thromboembolism in patients with end-stage kidney disease and atrial fibrillation.
Cadrenal Therapeutics (Nasdaq: CVKD) ha annunciato un prossimo incontro di tipo B con la FDA a settembre per discutere della sperimentazione clinica per il tecarfarin nei pazienti con LVAD. Il tecarfarin è un anticoagulante orale e reversibile di nuova generazione in fase avanzata, antagonista della vitamina K (VKA) progettato per prevenire infarti, ictus e decessi a causa di coaguli di sangue in pazienti con dispositivi cardiaci impiantati e rare condizioni cardiovascolari.
La società mira a soddisfare le esigenze non soddisfatte nella terapia anticoagulante, in particolare per i pazienti con LVAD che affrontano un rischio maggiore di eventi tromboembolici. Il tecarfarin ha ricevuto designazione di farmaco orfano per la prevenzione della trombosi nei pazienti con dispositivi di assistenza ventricolare, oltre a designazione di farmaco orfano e percorso accelerato per prevenire il tromboembolismo sistemico nei pazienti con malattia renale allo stadio terminale e fibrillazione atriale.
Cadrenal Therapeutics (Nasdaq: CVKD) ha anunciado una próxima reunión tipo B con la FDA en septiembre para discutir el ensayo clínico del tecarfarin en pacientes con LVAD. El tecarfarin es un anticoagulante oral y reversible de próxima generación, antagonista de la vitamina K (VKA) diseñado para prevenir infartos, accidentes cerebrovasculares y muertes debido a coágulos de sangre en pacientes con dispositivos cardíacos implantados y raras condiciones cardiovasculares.
La compañía tiene como objetivo abordar las necesidades no satisfechas en la terapia anticoagulante, particularmente para los pacientes con LVAD que enfrentan un riesgo aumentado de eventos tromboembólicos. El tecarfarin ha recibido designación de medicamento huérfano para la prevención de la trombosis en pacientes con dispositivos de asistencia ventricular, así como designaciones de medicamento huérfano y vía rápida para la prevención del tromboembolismo sistémico en pacientes con enfermedad renal en etapa terminal y fibrilación auricular.
캐드레날 제약(Cadrenal Therapeutics) (Nasdaq: CVKD)은 LVAD 환자에 대한 테카르파린의 임상 시험을 논의하기 위해 9월에 FDA와의 Type-B 회의를 예정하고 있다고 발표했습니다. 테카르파린은 후기 단계의 차세대 비타민 K 길항제(VKA) 경구용 및 가역적 항응고제로, 이식된 심장 기기와 희귀 심혈관 질환을 가진 환자에서 심장마비, 뇌졸중 및 혈전으로 인한 사망을 예방하기 위해 설계되었습니다.
회사는 특히 thromboembolic 사건의 위험이 증가하는 LVAD 환자를 위한 항응고 치료의 충족되지 않은 요구를 해결하는 것을 목표로 하고 있습니다. 테카르파린은 심실 보조 장치가 있는 환자의 혈전증 예방을 위한 희귀의약품 지정을 받았으며, 말기 신장 질환 및 심방 세동 환자의 전신 혈전색전증 예방을 위한 희귀의약품 및 신속심사 지정을 받았습니다.
Cadrenal Therapeutics (Nasdaq: CVKD) a annoncé une prochaine réunion de type B avec la FDA en septembre pour discuter de l'essai clinique du tecarfarin chez les patients LVAD. Le tecarfarin est un anticoagulant oral et réversible de nouvelle génération, antagoniste de la vitamine K (VKA) conçu pour prévenir les crises cardiaques, les AVC et les décès dus à des caillots sanguins chez des patients porteurs de dispositifs cardiaques implantés et de conditions cardiovasculaires rares.
L'entreprise vise à répondre aux besoins non satisfaits dans la thérapie anticoagulante, en particulier pour les patients LVAD qui font face à un risque accru d'événements thromboemboliques. Le tecarfarin a reçu la désignation de médicament orphelin pour la prévention de la thrombose chez les patients porteurs de dispositifs d'assistance ventriculaire, ainsi que des désignations de médicament orphelin et de voie rapide pour prévenir le thromboembolie systémique chez les patients atteints de maladie rénale au stade terminal et de fibrillation auriculaire.
Cadrenal Therapeutics (Nasdaq: CVKD) hat ein bevorstehendes Type-B-FDA-Meeting im September angekündigt, um die klinische Prüfung von Tecarfarin bei LVAD-Patienten zu besprechen. Tecarfarin ist ein spätstadien, neuartiger Vitamin-K-Antagonist (VKA), orales und reversibles Antikoagulans, das entwickelt wurde, um Herzinfarkte, Schlaganfälle und Todesfälle durch Blutgerinnsel bei Patienten mit implantierten Herzgeräten und seltenen Herz-Kreislauf-Erkrankungen zu verhindern.
Das Unternehmen zielt darauf ab, unerfüllte Bedürfnisse in der Antikoagulationstherapie zu adressieren, insbesondere für LVAD-Patienten, die einem erhöhten Risiko für thromboembolische Ereignisse ausgesetzt sind. Tecarfarin hat die Waisenarzneimittelbezeichnung zur Prävention von Thrombosen bei Patienten mit ventrikulären Hilfsgeräten erhalten, sowie die Bezeichnungen als Waisenarzneimittel und Beschleunigtes Prüfverfahren zur Verhinderung von systemischem Thromboembolismus bei Patienten mit terminaler Nierenkrankheit und Vorhofflimmern.
- Upcoming FDA Type-B meeting to discuss tecarfarin clinical trial for LVAD patients
- Tecarfarin has orphan drug and fast-track designations for multiple indications
- Tecarfarin has been evaluated in 11 human clinical trials with over 1,000 individuals
- Generally well-tolerated in Phase 1, Phase 2, and Phase 2/3 clinical trials
- Tecarfarin is still in late-stage development, not yet approved
- Potential competition from existing anticoagulation therapies like warfarin
This upcoming FDA meeting is a critical milestone for Cadrenal Therapeutics' tecarfarin development. The focus on LVAD patients highlights a significant unmet need in anticoagulation therapy. Current options like warfarin have limitations, including dosing variability and drug interactions.
Tecarfarin's potential advantages, such as its novel metabolism pathway, could address these challenges. The orphan drug and fast-track designations for various indications underscore the potential clinical importance of this drug. However, it's important to note that success in the FDA meeting and subsequent trials is not guaranteed. Investors should closely monitor the outcomes of this meeting, as it will significantly impact the company's development timeline and potential market positioning.
While this FDA meeting is a positive step for Cadrenal Therapeutics, investors should exercise caution. The company is still in the clinical development phase, with no guaranteed revenue stream. The anticoagulant market is highly competitive, dominated by established players.
However, Cadrenal's focus on niche indications like LVAD patients and orphan designations could provide a competitive edge if tecarfarin proves successful. The company's narrow pipeline centered on tecarfarin presents both opportunity and risk. Positive trial results could lead to significant upside, but any setbacks could severely impact the stock. Investors should consider Cadrenal as a high-risk, high-reward opportunity within the biotech sector, with its near-term performance likely tied to the outcomes of this FDA meeting and subsequent clinical developments.
"This upcoming meeting with the FDA is a crucial step in developing tecarfarin as we prepare for our pivotal trial. We look forward to discussing the development program for tecarfarin in LVAD patients," said Quang Pham, Chief Executive Officer of Cadrenal Therapeutics.
ABOUT LVAD PATIENTS
Left Ventricular Assist Devices (LVADs) are mechanical pumps to support heart function in patients with advanced heart failure. These devices are vital for patients awaiting heart transplants or those who are ineligible for transplants. However, LVAD patients face an increased risk of thromboembolic events, such as strokes, which necessitates ongoing anticoagulation therapy. The current anticoagulation therapy, warfarin, presents challenges, including variability in dosing, a narrow therapeutic window, and potential interactions with other medications, making effective management crucial to reducing complications and ensuring patient safety.
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 implanted cardiac devices and those with rare cardiovascular conditions. Tecarfarin has orphan drug designation for the prevention of thrombosis and thromboembolism in patients with ventricular assist devices. Tecarfarin also 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 and atrial fibrillation. Cadrenal is also pursuing additional regulatory strategies for unmet needs in anticoagulation therapy for patients 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 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 Company engaging with the FDA in early September for a Type-B meeting to discuss its clinical trial for tecarfarin in LVAD patients and the planned pivotal 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 anticoagulation treatment in patients, the success of the Type-B meeting, the ability of the Company to commence and complete a pivotal trial and commercialize tecarfarin with 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, 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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