FDA designation provides potentially seven
years of market exclusivity after approval and expanded partnering
opportunities for tecarfarin
PONTE
VEDRA, Fla., April 9,
2024 /PRNewswire/ -- Cadrenal
Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical
company developing tecarfarin, a late-stage novel oral and
reversible anticoagulant (blood thinner) designed to prevent heart
attacks, strokes, and deaths due to blood clots in patients with
rare cardiovascular conditions, announced today that the United
States Food and Drug Administration (FDA) has granted tecarfarin
Orphan Drug Designation (ODD) for the prevention of thromboembolism
and thrombosis in patients with an implanted mechanical circulatory
support device (left ventricular assist device (LVAD), right
ventricular assist device (RVAD), collectively known as ventricular
assist devices (VADs), biventricular assist device, and total
artificial heart).
"This second orphan drug designation
highlights the expanded need for tecarfarin where existing
anticoagulation therapies are inadequate," said Quang Pham, Founder, Chairman and Chief
Executive Officer of Cadrenal Therapeutics. "We are
dedicated to advancing tecarfarin through clinical
development options as swiftly as
possible."
The FDA's ODD program provides incentives to sponsor
organizations for the development of innovative treatments for rare
diseases that affect fewer than 200,000 people in the U.S. Since
its adoption in 1983, the Orphan Drug Act has helped countless
individuals living with these conditions gain access to
life-enhancing and life-saving therapies. ODD also provides certain
benefits to drug developers, including assistance in the drug
development process, tax credits for certain clinical research, and
a waiver of the New Drug Application user fee. The designation is
made to promote safe and efficacious products for the treatment of
rare conditions.
All patients with VADs require chronic anticoagulation to
prevent the formation of thrombus (clot) which can cause the device
to fail or can result in a clot breaking off (embolizing),
resulting in a stroke or other vascular catastrophe.
The current market-leading direct oral anticoagulants (DOACs),
such as Eliquis, are not indicated for patients with VADs due to a
lack of evidence of benefit. Moreover, a recent study revealed that
the level of anticoagulation achieved with warfarin, the only
currently available Vitamin K Antagonist (VKA), is maintained in
the target range only 56% of the time which has been shown to
increase the risk of clotting and bleeding complications.
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
rare cardiovascular conditions. Tecarfarin 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 (ESKD) and atrial fibrillation (AFib) and
just received orphan drug designation for the prevention of
thrombosis and thromboembolism in patients with ventricular assist
devices (VADs). 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 eleven (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 tecarfarin addressing unmet needs in
anticoagulation therapy and the ability to derive the anticipated
and potential benefits from the recent Orphan Drug Designation for
tecarfarin, including seven years of market
exclusivity, and the expanded development and
commercial partnering for tecarfarin as a result of the Orphan Drug
Designation. 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
Company's ability to derive the anticipated benefits from the
recent Orphan Drug Designation for tecarfarin 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 filings with the Securities and Exchange
Commission, including 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.