Full Press Release Details
Cadrenal Therapeutics and Abbott Initiate Collaborative
Effort to Advance Novel Anticoagulant Tecarfarin for Patients with LVADs
PONTE VEDRA, Fla., Aug. 6, 2024 /PRNewswire/ -- Cadrenal
Therapeutics, Inc., (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a late-stage, new-generation Vitamin K Antagonist
(VKA) oral and reversible anticoagulant (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, announced today that it has been in discussions with
Abbott (NYSE: ABT) about Cadrenal's planned pivotal study of tecarfarin in patients with recently implanted LVADs. All patients with LVADs
require lifelong anticoagulation (AC) to protect against thromboembolic events.
In April 2024, tecarfarin received FDA Orphan Drug Designation (ODD)
to prevent blood clots and strokes in patients with implanted mechanical circulatory support devices such as LVADs.
Currently, the only LVAD available in the United States is the HeartMate
3 , manufactured by Abbott, which has been shown to be superior to all prior LVADs.
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
"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
ABOUT CADRENAL THERAPEUTICS, INC.
Cadrenal Therapeutics is developing tecarfarin for unmet needs in anticoagulation
therapy. Tecarfarin is a new-generation Vitamin K Antagonist (VKA) 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 from the FDA for the prevention of thrombosis and thromboembolism (blood clots) in patients with an implanted
mechanical circulatory support device, which includes the left ventricular assist device (LVAD). Tecarfarin also has orphan drug and fast-track
designations from the FDA for the prevention of systemic thromboembolism of cardiac origin in patients with end-stage kidney disease (ESKD)
and atrial fibrillation (AFib). Tecarfarin is specifically designed to use a different metabolism pathway than the oldest and most commonly
prescribed VKA warfarin. Tecarfarin has been evaluated in eleven (11) human clinical trials in 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 Cadrenal's planned pivotal study of tecarfarin in patients with recently
implanted LVADs, maintaining high-quality AC resulting in further improvement of outcomes with the HeartMate 3 LVAD, the collaborative
effort with Abbott for the trial being very important to LVAD patients and tecarfarin having the potential to further improve AC treatment
for HeartMate 3 patients. 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
outcomes in patients with a HeartMate 3, the ability of the Company to advance tecarfarin with patients with left ventricular assist devices
(LVADs), and those with AFib and ESKD, the collaboration 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 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:
Lytham Partners, LLC
Robert Blum, Managing Partner