MedPath

Tecarfarin Shows Promise in LVAD Patients with Potential to Improve Anticoagulation

• 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.

Cadrenal Therapeutics highlighted a presentation at the European Association for Cardio-thoracic Surgery (EACTS) Mechanical Circulatory Support Summit in November 2024, featuring tecarfarin and its potential in patients with the Abbott HeartMate3 (HM3) left ventricular assist device (LVAD). The presentation, titled Tec arfarin and H emocompatibility with LVAD Therapy (TECH-LVAD), outlined Cadrenal's proposed clinical trial protocol submitted to the FDA.
Dr. Mandeep R. Mehra, from Brigham and Women's Hospital and Harvard University, presented data demonstrating the inverse relationship between bleeding rates and time in therapeutic range (TTR) for HM3 patients. He also highlighted evidence from prior studies suggesting tecarfarin's potential to improve TTR. The data included a trial in end-stage kidney disease (ESKD) patients, showing that ESKD does not alter tecarfarin exposure, unlike warfarin, which sees increased exposure. This is a critical differentiator, as many LVAD patients have kidney impairment.

TECH-LVAD Trial Design

The proposed TECH-LVAD trial aims to study tecarfarin as a VKA option to reduce bleeding events associated with HM3 LVAD use in advanced heart failure. According to Dr. Mehra, tecarfarin could be an important therapy for LVAD patients requiring chronic anticoagulation.

Clinical Significance

Cadrenal Therapeutics is developing tecarfarin as 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. Tecarfarin received 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.
Quang X. Pham, CEO of Cadrenal Therapeutics, stated that increasing tecarfarin data visibility will help accelerate development as they plan for investigator outreach and patient recruitment for the tecarfarin trial. The company is also planning pivotal clinical trials and pursuing clinical and commercial partnerships to advance tecarfarin, including studying its use in patients with mechanical heart valves experiencing anticoagulation difficulties.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

Cadrenal Therapeutics Plans Phase 3 Trial for Tecarfarin 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.

Medtronic's Evolut TAVR System Shows Positive Outcomes in Aortic Stenosis Treatment

Medtronic's Optimize PRO study demonstrates positive outcomes using the cusp overlap technique (COT) with the Evolut TAVR system in treating severe aortic stenosis.
The study reported a low 30-day permanent pacemaker implantation rate of 6.4% with COT compliance and no moderate or severe aortic regurgitation at discharge.

Acoramidis Gains Global Momentum: FDA Approval, EU Recommendation, and Promising Clinical Data

Acoramidis (Attruby), developed by Stanford Medicine and BridgeBio, receives FDA approval for transthyretin amyloid cardiomyopathy (ATTR-CM) treatment, marking a significant milestone.
The European Medicines Agency's CHMP recommends acoramidis for EU marketing authorization based on positive Phase 3 ATTRibute-CM trial results.

FDA Approves Attruby (Acoramidis) for ATTR-CM, Reducing Cardiovascular Death and Hospitalization

The FDA has approved Attruby (acoramidis) for treating adults with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM), addressing both wild-type and variant forms of the disease.
Attruby, an oral TTR stabilizer, demonstrated a significant reduction in cardiovascular death and cardiovascular-related hospitalizations in the Phase 3 ATTRibute-CM trial.

Acoramidis Approved for ATTR-CM, Showing Sustained Benefits in Long-Term Study

The FDA has approved acoramidis (Attruby) for transthyretin amyloid cardiomyopathy (ATTR-CM) to reduce cardiovascular death and hospitalization.
Acoramidis demonstrated a 42% reduction in all-cause mortality and cardiovascular-related hospitalization events compared to placebo at 30 months.

Tecarfarin Shows Promise in Reducing Bleeding Events in LVAD Patients

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.

Cadrenal Therapeutics Highlights Tecarfarin Data for LVAD Patients at EACTS Summit

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.

TCT Conference Highlights: Edwards, Medtronic, and Inari Share Key Trial Data

Edwards Lifesciences' tricuspid valve replacement device met its primary endpoint in a trial, showing improvement in patient-reported quality of life but no significant mortality benefit at 12 months.
Medtronic's Symplicity Spyral renal denervation device demonstrated sustained blood pressure reduction over two years compared to a sham procedure in hypertension patients.

Triumvira Immunologics Presents Promising Phase 1 Data for TAC101-CLDN18.2 in Solid Tumors

Triumvira Immunologics presented initial Phase 1/2 data for TAC101-CLDN18.2, a novel T cell therapy targeting Claudin 18.2+ advanced solid tumors, at SITC 2024.
The TACTIC-3 trial evaluates the safety and efficacy of TAC101-CLDN18.2 in patients with advanced gastric and other solid tumors expressing Claudin 18.2.

Cadrenal Therapeutics' Tecarfarin Advances to Phase 3 for Thrombosis Prevention

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).

Reference News

[1]
Cadrenal Therapeutics Announces Upcoming Type-B FDA Meeting ...
prnewswire.com · Aug 22, 2024
[2]
Cadrenal's Tecarfarin Shows Promise for LVAD Patients in Key Medical Congress Data
stocktitan.net · Nov 12, 2024

Cadrenal Therapeutics presented tecarfarin data and proposed clinical trial protocol at the 8th EACTS Mechanical Circula...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy