NEW
YORK, Aug. 30, 2023 /PRNewswire/ -- Cadrenal
Therapeutics, Inc., (Nasdaq: CVKD) a biopharmaceutical company
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, today announced the expanded evaluation of tecarfarin
for the treatment of patients with antiphospholipid syndrome (APS)
who require chronic anticoagulation.
APS, formerly known as Hughes Syndrome or Sticky Blood in the
United Kingdom, is a disorder of
the immune system that causes an increased risk of blood clots.
Normally, antibodies protect a person's body from viruses,
bacteria, etc., but in APS, antibodies attack the body's healthy
cells. High levels of APS antibodies raise the risk of blood clots.
The specific antibodies in APS are called 'antiphospholipids'
because they attack and damage parts of cells called phospholipids.
The damage increases the chance that blood clots will form in both
veins and arteries. Patients with APS who receive direct oral
anticoagulants (DOACs) may have an increased risk for arterial
thrombosis compared with those who receive Vitamin K antagonists
(VKAs) such as warfarin, according to a study in the Journal of the
American College of Cardiology.
"Antiphospholipid syndrome is a rare medical condition and blood
clotting disorder affecting approximately 167,000 patients in
the United States which currently
has no cure. Effective anticoagulation (with blood thinners) should
prevent health problems caused by the condition with the goal of
treatment to prevent blood clots from forming and to keep existing
clots from getting larger," commented Douglas Losordo, Chief Medical Officer of
Cadrenal Therapeutics. "However, the only widely prescribed
anticoagulant approved for this patient population is warfarin, a
70-year-old drug, which fails to achieve sufficiently reliable
anticoagulation due to the way in which it is metabolized. We
believe tecarfarin, which is specifically designed to solve
warfarin's metabolism problem by using an alternate pathway, could
provide improved outcomes for this patient population. Tecarfarin's
metabolic pathway is abundant and essentially insaturable, which
results in a reliable, stable pharmacokinetic profile."
Based on clinical data, market research, and insights from key
industry experts, the Company believes tecarfarin is ideally
positioned to target rare medical conditions where warfarin fails
to achieve sufficiently stable anticoagulation and Direct Oral
Anticoagulants (DOACs) are not widely prescribed. Currently,
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). 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. Currently, tecarfarin has
orphan drug and Fast Track designations for the prevention of
systemic thromboembolism (blood clots) of cardiac origin in
patients with end-stage renal disease, and atrial fibrillation
providing for 7-year marketing exclusivity.
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
end-stage renal disease, and atrial fibrillation. 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."
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. These statements include statements
regarding patients with APS who receive direct oral anticoagulants
(DOACs) having an increased risk for arterial thrombosis
compared with those who receive Vitamin K antagonists
(VKAs); effective anticoagulation (blood thinners) preventing
health problems; tecarfarin being ideally positioned to target rare
medical conditions where warfarin fails to achieve sufficiently
stable anticoagulation and Direct Oral Anticoagulants (DOACs) are
not widely prescribed; tecarfarin providing improved outcomes
for patients with APS; and End Stage Kidney Disease (ESKD) with
Atrial Fibrillation (AFib); Left Ventricular Assist Devices
(LVADs); and Antiphospholipid Syndrome (APS) presenting at U.S.
market opportunity in excess of $2
billion.
Actual results may differ materially from those indicated by
such forward-looking statements as a result of various important
factors, including the ability to successfully advance tecarfarin
for the treatment of rare medical conditions including patients
with APS who require chronic anticoagulation; the ability to assess
the size of the U.S. market opportunity for patients with End Stage
Kidney Disease (ESKD) with Atrial Fibrillation (AFib); Left
Ventricular Assist Devices (LVADs); and Antiphospholipid Syndrome
(APS) 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.