Ponte Vedra-based biopharmaceutical company Cadrenal Therapeutics Inc. (Nasdaq: CVKD), announced Tuesday it's in discussions with Abbott (NYSE: ABT) about upcoming medical studies concerning its drug that was recently granted FDA Orphan Drug Designation.
Cadrenal, a biopharmaceutical company developing tecarfarin, a late-stage, new-generation 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, is planning a pivotal study of tecarfarin in patients with recently implanted LVADs.
The only LVAD available in the United States is the HeartMate 3, manufactured by Abbott. All patients with LVADs require lifelong anticoagulation to protect against thromboembolic events.
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.
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