PONTE
VEDRA, Fla., Aug. 22,
2024 /PRNewswire/ -- Cadrenal Therapeutics, Inc.
(Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin,
a late-stage, next-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 will be engaging with the U.S.
Food and Drug Administration (FDA) in early September for a Type-B
meeting to discuss its clinical trial for tecarfarin in LVAD
patients.
"This upcoming meeting with the FDA is a crucial step in
developing tecarfarin as we prepare for our pivotal trial. We look
forward to discussing the development program for tecarfarin in
LVAD patients," said Quang Pham,
Chief Executive Officer of Cadrenal Therapeutics.
ABOUT LVAD PATIENTS
Left Ventricular Assist Devices (LVADs) are mechanical pumps to
support heart function in patients with advanced heart failure.
These devices are vital for patients awaiting heart transplants or
those who are ineligible for transplants. However, LVAD patients
face an increased risk of thromboembolic events, such as strokes,
which necessitates ongoing anticoagulation therapy. The current
anticoagulation therapy, warfarin, presents challenges, including
variability in dosing, a narrow therapeutic window, and potential
interactions with other medications, making effective management
crucial to reducing complications and ensuring patient safety.
ABOUT CADRENAL THERAPEUTICS, INC.
Cadrenal Therapeutics is developing tecarfarin for unmet needs in
anticoagulation therapy. Tecarfarin is a late-stage novel 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 for the prevention of
thrombosis and thromboembolism in patients with ventricular assist
devices. Tecarfarin also has orphan drug and fast-track
designations from the FDA for the prevention of systemic
thromboembolism (blood clots) of cardiac origin in patients with
end-stage kidney disease and atrial fibrillation. Cadrenal is also
pursuing additional regulatory strategies for unmet needs in
anticoagulation therapy for patients with thrombotic
antiphospholipid syndrome (APS). Tecarfarin is specifically
designed to leverage a different metabolism pathway than the oldest
and most commonly prescribed Vitamin K Antagonist (warfarin).
Tecarfarin has been evaluated in 11 human clinical trials and 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 the Company engaging with the FDA in early September for
a Type-B meeting to discuss its clinical trial for tecarfarin in
LVAD patients and the planned pivotal trial. 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
anticoagulation treatment in patients, the success of the Type-B
meeting, the ability of the Company to commence and complete a
pivotal trial and commercialize tecarfarin with patients with left
ventricular assist devices (LVADs), 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.