- Analysis features the growing need to evolve anticoagulation
therapy beyond warfarin to avoid gastrointestinal bleeding, a
significant and common complication for left ventricular assist
device (LVAD) patients resulting in expensive hospitalizations
- Tecarfarin, a novel vitamin K antagonist (VKA), uses a
different metabolic pathway than warfarin, the most commonly used
anticoagulant for LVAD patients, and may offer more stable and
effective anticoagulation
PONTE
VEDRA, Fla., Aug. 20,
2024 /PRNewswire/ -- Cadrenal Therapeutics,
Inc., (Nasdaq: CVKD), a biopharmaceutical company
developing tecarfarin, a late-stage, next-generation 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 or rare cardiovascular
conditions, today highlighted a manuscript that was recently
peer-reviewed and published in the Journal of Cardiac Failure
evaluating the relationship between time in therapeutic range, or
TTR, management quality and LVAD patient clinical outcomes. These
findings focus on the potential role of investigating new VKA
agents beyond warfarin in improving clinical outcomes in LVAD
patients.
In the manuscript co-authored by Mandeep
R. Mehra, MD, MSc, FRCP, Brigham and Women's Hospital Heart
and Vascular Center, Center for Advanced Heart Disease, titled
"Antithrombotic Strategies with Left Ventricular Devices," the
findings conclude that although the current generation of LVAD
pumps has largely overcome hemocompatibility-related adverse events
there is a continuing need to evolve the anticoagulant therapy to
avoid persistent gastrointestinal bleeding, which leads to frequent
hospital admissions, procedures, blood transfusions, decreased
quality of life and increased cost of care.1
Dr. Mandeep Mehra, who chaired the ARIES-HM3 study,
commented, "Tecarfarin could potentially be an important therapy
for patients with LVADs who all require chronic anticoagulation
since it does not get affected by drug-drug interactions or changes
in kidney function like warfarin and deserves further study."
A secondary analysis of the ARIES-HM3 trial, sponsored by
Abbott, evaluated the relationship between VKA management quality
and clinical outcomes, wherein a median TTR for VKAs of 56% was
achieved. This analysis found an inverse relationship between TTR
and bleeding events, with a 47% reduction in bleeding risk for
patients with a TTR above the median. Lower TTRs were associated
with threefold more sub-therapeutic INRs than supra-therapeutic
INRs, with no clear correlation between higher INRs and bleeding
events.
"These findings provide us with increased confidence that
tecarfarin has the potential to address the LVAD patients' critical
unmet anticoagulation needs more effectively," said Quang X.
Pham, Chairman and Chief Executive Officer of Cadrenal
Therapeutics. "We are excited to work with the LVAD community to
potentially bring our next-generation VKA to patients."
About Tecarfarin
Tecarfarin is the only oral
anticoagulant in development worldwide for patients with implanted
cardiac devices and other rare cardiovascular conditions. It has
been uniquely designed to overcome many of the challenges patients
experience with warfarin. Tecarfarin is metabolized using carboxyl
esterase rather than the cytochrome P450 system, which allows the
drug to avoid interactions with many other commonly used
medications and may offer more stable anticoagulation, including
those patients with renal dysfunction, which is common in LVAD
patients. In a Phase II study with 66 patients with atrial
fibrillation switched from warfarin to tecarfarin, the mean
interpolated TTR was 71.4% within three weeks, with minimal time
spent in extreme INR ranges (<1.5 and >4.0). If approved,
tecarfarin has the potential to be the only on-label drug for LVAD
patients in the U.S.
In addition, tecarfarin may prove valuable for other patients
where warfarin is not providing recommended anticoagulation because
of genetic warfarin resistance or renal impairment making warfarin
metabolism difficult. These include individuals with end-stage
kidney disease and atrial fibrillation or those with mechanical
heart valves and hard-to-control International Normalized Ratio,
which measures how long it takes the blood to clot.
On August 6, 2024, Cadrenal
Therapeutics announced that it had been in discussions with Abbott
about Cadrenal's planned pivotal study of tecarfarin in patients
with recently implanted LVADs. LVAD patients require lifelong
anticoagulation to protect against thromboembolic events. The
only LVAD available in the U.S. is Abbott's HeartMate
3TM.
On April 9, 2024, Cadrenal Therapeutics announced that the
U.S. Food and Drug Administration (FDA) had granted tecarfarin
Orphan Drug Designation for the prevention of thromboembolism and
thrombosis in patients with an implanted mechanical circulatory
support device, which includes the LVAD.
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 an orphan drug designation for the prevention of
thrombosis and thromboembolism in patients with ventricular assist
devices (VADs). 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. 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 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 offering more
stable and effective anticoagulation than warfarin, the potential
role of investigating new VKA agents beyond warfarin in improving
clinical outcomes in LVAD patients, the continuing need to
evolve the anticoagulant therapy to avoid persistent
gastrointestinal bleeding and tecarfarin potentially being an
important therapy for patients with LVADs who all require chronic
anticoagulation since it does not get affected by drug-drug
interactions or changes in kidney function like warfarin,
tecarfarin having the potential to address the LVAD patients'
critical unmet anticoagulation needs more effectively
and potentially bringing the Company's r next-generation VKA
to 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 anticoagulation treatment in
patients, the ability of the Company to advance 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.