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 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.
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:
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.