Tecarfarin is the
only known Novel Vitamin K Antagonist in
Development
PONTE
VEDRA, Fla., Sept. 5,
2023 /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 certain rare medical
conditions, today cited recent data that underscores additional
need for an improved Vitamin K Antagonist (VKA). The Company
believes tecarfarin is the solution for this unmet need.
At the recent European Society of Cardiology Congress (ESC) in
Amsterdam, The Netherlands, the
open-label "FRAIL-AF" trial was presented, revealing that switching
International Normalized Ratio (INR)-guided VKA treatment to direct
oral anticoagulants (DOACs aka NOACs) in frail older patients with
Atrial Fibrillation (AFib) was associated with more bleeding
complications compared to continuing VKA treatment, without an
associated reduction in thromboembolic complications. Reports
indicate that this unique trial was stopped early for futility in
seeking superiority for the direct oral anticoagulant (DOAC)
strategy. FRAIL-AF was deemed the most important study from ESC,
according to Medscape.
In the report, study author Geert-Jan Geersing, MD, PhD, of the
University Medical Center Utrecht in the
Netherlands, at the ESC Congress concluded that "Switching
from a VKA to a NOAC should not be considered without a clear
indication in frail older patients with AFib."
Cadrenal is developing tecarfarin, a novel Vitamin K Antagonist,
targeted for indications where existing VKAs fail to achieve
sufficiently stable anticoagulation and DOACs (Eliquis-class drugs)
are not widely prescribed.
"The findings of the FRAIL-AF study highlight the benefits of
VKAs compared to DOACs in an additional unique patient population,"
commented Quang Pham, CEO of
Cadrenal Therapeutics. "Tecarfarin, an enhanced VKA, avoids the
existing metabolism problems of currently available VKAs by using
an alternate metabolic pathway. We believe tecarfarin will provide
improved outcomes for patients with certain rare medical
conditions. Cadrenal has identified three such rare medical
conditions: End-Stage Kidney Disease (ESKD) with Atrial
Fibrillation (AFib); Left Ventricular Assist Devices (LVADs); and
Antiphospholipid Syndrome (APS)."
Currently, tecarfarin has orphan drug and Fast Track
designations for the prevention of systemic thromboembolism (blood
clots) of cardiac origin in patients with ESKD and AFib, providing
for 7-year marketing exclusivity.
Based on management's market analysis studies and expected
adoption rates, these three rare medical conditions present a U.S.
market opportunity in excess of $2
billion per year.
ABOUT CADRENAL THERAPEUTICS, INC.
Cadrenal Therapeutics is developing tecarfarin, a late-stage
novel oral and reversible anticoagulant (blood thinner), to prevent
heart attacks, strokes, and deaths due to blood clots in patients
with certain rare medical conditions. Tecarfarin has orphan drug
and Fast Track designations for the prevention of systemic
thromboembolism (blood clots) of cardiac origin in patients with
ESKD and AFib. Tecarfarin is specifically designed to leverage a
different metabolism pathway than the oldest and most commonly
prescribed Vitamin K Antagonist (warfarin) used in the prevention
of thrombosis. 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 being the solution for an improved Vitamin K
Antagonist, tecarfarin providing improved outcomes for patients
with certain rare medical conditions and End-Stage Kidney Disease
with Atrial Fibrillation; Left Ventricular Assist Devices;
and Antiphospholipid Syndrome presenting a U.S. market
opportunity in excess of $2 billion
per year.
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
be an improved Vitamin K Antagonist, the ability to advance
tecarfarin within patients with rare medical conditions, the
ability to penetrate the U.S. market for patients with End-Stage
Kidney Disease with Atrial Fibrillation; Left Ventricular Assist
Devices; and Antiphospholipid Syndrome and the other risk factors
described in the Company's Annual Report on Form 10-K for the year
ended December 31, 2022, 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.