Cadrenal Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which focused on developing novel therapy. It develops tecarfarin, a novel therapy with orphan drug indication, designed for the prevention of systemic thromboembolism of cardiac origin in patients with end-stage renal disease and atrial fibrillation. The company was founded by Quang Pham and Matthew Szot on January 25, 2022 and is headquartered in Ponte Vedra, FL.
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2022
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- Cadrenal Therapeutics has acquired VLX-1005, a first-in-class 12-lipoxygenase inhibitor targeting heparin-induced thrombocytopenia (HIT), a life-threatening complication affecting up to 5% of heparin-exposed patients. - The drug candidate has demonstrated encouraging safety and efficacy results in Phase 2 trials, with interim data showing reductions in thromboembolic events in suspected HIT patients. - VLX-1005 has received FDA Orphan Drug and Fast Track designations, positioning Cadrenal to address a $1 billion market opportunity in the US and EU.
- Cadrenal Therapeutics acquired eXIthera Pharmaceuticals' portfolio of Factor XIa inhibitors, including Phase 2-ready frunexian and IND-ready EP-7327, targeting the $38 billion global anticoagulation market. - The acquisition positions Cadrenal as the only company developing both novel vitamin K antagonists and Factor XIa inhibitors, addressing critical gaps in anticoagulation therapy. - Factor XIa inhibitors offer mechanism-based anticoagulation with high potency and selectivity, potentially reducing bleeding risks compared to current broad-spectrum anticoagulants. - The deal includes up to $15 million in milestone payments and royalties, with Sichuan Haisco retaining Chinese rights to frunexian following successful Phase 1 trials.
- Cadrenal Therapeutics is preparing for a pivotal Phase 3 trial of tecarfarin specifically targeting patients with Left Ventricular Assist Devices (LVADs), addressing an important anticoagulation need in this population. - The company has secured Abbott as a strategic partner for the upcoming trial, leveraging Abbott's extensive experience with LVAD patients and clinical trials to strengthen the study design and execution. - Despite having approximately $7.3 million in cash as of March 2025, Cadrenal will need to raise additional capital to fully fund the planned Phase 3 trial while continuing to utilize its ATM facility for interim financing.
- Cadrenal Therapeutics and Abbott have formed a strategic collaboration to evaluate tecarfarin, a new oral Vitamin K antagonist, in patients with HeartMate 3 left ventricular assist devices. - Abbott will provide crucial support for the TECH-LVAD trial, including trial design expertise, site identification, and insights from recent HeartMate 3 trials. - The partnership aims to develop the first innovation in vitamin K-targeted anticoagulation in over 70 years, addressing the limitations of warfarin in LVAD patients.
- Cadrenal Therapeutics aims to initiate a Phase 3 clinical trial for tecarfarin in LVAD patients in 2025, following discussions with the FDA. - Tecarfarin received FDA Orphan Drug Designation for preventing thromboembolism in LVAD patients and Fast Track designation for ESKD patients with AFib. - The company is exploring collaborations to advance tecarfarin's clinical trial and improve anticoagulation outcomes for patients with rare cardiovascular conditions. - Clinical data suggests tecarfarin may offer a safer alternative to warfarin for LVAD patients, addressing limitations of current anticoagulation treatments.
- Dr. Mandeep Mehra presented data on tecarfarin's potential to improve Time in Therapeutic Range (TTR) in patients with Abbott HeartMate3 LVADs at the EACTS Summit. - A proposed clinical trial, TECH-LVAD, aims to evaluate tecarfarin versus warfarin in LVAD patients, focusing on reducing bleeding events associated with HM3 use. - Tecarfarin's pharmacokinetics are unaffected by end-stage kidney disease (ESKD), a common comorbidity in LVAD patients, unlike warfarin. - Cadrenal Therapeutics is advancing discussions with the FDA and Abbott to initiate the TECH-LVAD trial, with plans for investigator outreach and patient recruitment.
- Tecarfarin's data and Cadrenal's trial protocol were presented at the EACTS Mechanical Circulatory Support Summit, focusing on LVAD patients. - Data suggests tecarfarin may improve Time in Therapeutic Range (TTR) and reduce bleeding events compared to warfarin in HM3 LVAD patients. - The TECH-LVAD trial, submitted to the FDA, aims to evaluate tecarfarin versus warfarin in patients with the Abbott HeartMate3 LVAD. - Tecarfarin's pharmacokinetics are not affected by end-stage kidney disease, unlike warfarin, making it suitable for LVAD patients with renal impairment.
- Tecarfarin's potential to improve Time in Therapeutic Range (TTR) and reduce bleeding events in HeartMate3 LVAD patients was presented at the EACTS Summit. - A proposed clinical trial protocol, TECH-LVAD, aims to evaluate tecarfarin versus warfarin in LVAD patients, addressing the need for safer anticoagulation options. - Data from past trials suggest tecarfarin exposure is not altered by end-stage kidney disease, a common comorbidity in LVAD patients, unlike warfarin. - Cadrenal Therapeutics is progressing discussions with the FDA and Abbott to advance the tecarfarin study in LVAD patients, planning for investigator outreach and patient recruitment.
- Cadrenal Therapeutics is advancing tecarfarin, a novel oral anticoagulant, into a Phase 3 trial for preventing blood clots in patients with left ventricular assist devices (LVADs). - Tecarfarin has received Orphan Drug Designation for LVADs and Fast Track status for end-stage kidney disease (ESKD) patients with atrial fibrillation (AFib). - Tecarfarin offers a metabolic advantage over warfarin, potentially reducing adverse events and drug-drug interactions due to its unique metabolism pathway. - The Phase 3 trial design is underway, with final protocol announcement expected in Fall 2024, marking a significant step toward addressing unmet needs in anticoagulation therapy.
