Tecarfarin, which recently received Orphan
Drug Designation from the FDA for the prevention of
thromboembolism and thrombosis in patients with an
implanted mechanical circulatory support device, has the potential
to improve the time in therapeutic range a factor correlated in the
ARIES-HM3 trial with better patient outcomes
PONTE
VEDRA, Fla., June 3, 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, today
highlighted a groundbreaking presentation at the International
Society for Heart & Lung Transplantation (ISHLT) 44th Annual
Meeting & Scientific Sessions.
These new findings from secondary analyses of the ARIES-HM3
trial were released in a presentation titled, "Impact of Vitamin K
Antagonist (VKA) Therapy On Outcomes In a Randomized Controlled
Trial of Aspirin Removal In Left Ventricular Assist Device (LVAD)
Patients - A Pre-Specified Analysis From the Aspirin and
Hemocompatibility Events With a Left Ventricular Assist Device in
Advanced Heart Failure, or the ARIES-HM3, Randomized Clinical
Trial."
The ARIES-HM3 trial data demonstrated that lower time in
therapeutic range, or TTR, translated directly to excessive
bleeding events. The "average" patient in the ARIES-HM3 study had a
30% rate of serious bleeding events even after aspirin was
eliminated as part of the antithrombotic regimen, and persistent
bleeding was inversely correlated with TTR.
The ARIES-HM3 clinical study was sponsored by Abbott
(NYSE: ABT), which evaluated a new clinical approach to
patient management that included removal of aspirin as part of the
antithrombotic regimen warfarin. The data is currently under review
by the FDA. Labeling changes related to the antithrombotic regimen
have not been approved by the FDA at this time.
Dr. Mandeep Mehra, who chaired
the ARIES-HM3 study, holds the William Harvey Distinguished Chair
in Advanced Cardiovascular Medicine and is Executive Director of
the Center for Advanced Heart Disease at Brigham and Women's
Hospital, commented, "This comprehensive analysis identifies
adequacy of VKA use (as measured by TTR) as a significant risk
marker for bleeding events and provides new clinical direction for
further mitigation of bleeding to enhance hemocompatibility with
the HeartMate 3 LVAD." Mehra continued, "Each incremental
improvement of 10% above the median of 56% TTR trends in a
significant further reduction in bleeding rate. Tecarfarin could
potentially be an important therapy for patients with LVADs who all
require chronic anti-coagulation since it does not get affected by
drug-drug interactions or changes in kidney function like warfarin
and deserves further study."
"The ARIES-HM3 trial data underscores the deficiencies of
warfarin and the need for a new VKA therapy for patients with
LVADs. We believe our drug candidate, the next-generation VKA
tecarfarin, with its unique retrometabolic design that provides for
more stable anticoagulation than warfarin, is the much-needed
replacement therapy. We intend to pursue a pivotal trial evaluating
tecarfarin effectiveness for LVAD patients," said Quang Pham, Founder, Chairman and Chief
Executive Officer of Cadrenal Therapeutics. "Cadrenal commends
Abbott's commitment to LVAD patients in sponsoring this important
trial and analyses."
On April 9, 2024, Cardenal
Therapeutics announced that the United States 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 left ventricular assist device (LVAD).
The current market-leading direct oral anticoagulants (DOACs),
such as Eliquis, are not indicated for patients with LVADs due to a
lack of evidence of benefit, while the level of anticoagulation
achieved with warfarin was achieved in the target range only 56% of
the time in the ARIES-HM3 trial. Patients whose level of
anticoagulation was in the therapeutic range > 56% had better
outcomes than those with lower levels. This highlights the
potential role for investigating new VKA agents in improving
clinical outcomes in LVAD patients.
VKA anticoagulation is prescribed for the prevention of
LVAD-related clotting. However, the only available VKA is warfarin,
which was approved for human use in 1954. Tecarfarin has been shown
to improve TTR, particularly in patients taking multiple
medications, and be more stable in patients with renal dysfunction
which is common in LVAD patients.
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 a
next-generation Vitamin K Antagonist (VKA) specifically designed to
use a different metabolism pathway than the oldest and most
commonly prescribed VKA 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 having the
potential to improve the time in therapeutic range which analysis
of the ARIES-HM3 trial reveals is associated with better patient
outcomes. TTRs as predicting increased risk for bleeding
events, the VKA tecarfarin, filling the market void for a
next-generation VKA, the Company pursuing a pivotal trial
evaluating tecarfarin effectiveness for LVAD 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 the time in
therapeutic range, the ability of the Company to advance
tecarfarin with patients with left ventricular assist devices
(LVADs), thrombotic APS, and those with AFib and ESKD 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.