Leading heart failure specialist features
tecarfarin data and Cadrenal's proposed clinical trial protocol at
8th EACTS Mechanical Circulatory Support Summit
PONTE
VEDRA, Fla., Nov. 12,
2024 /PRNewswire/ -- Cadrenal Therapeutics, Inc.,
(Nasdaq: CVKD), a late-stage biopharmaceutical company developing
tecarfarin, a new vitamin K antagonist (VKA) anticoagulant, today
highlighted a key opinion leader presentation at the November
2024 European Association for Cardio-thoracic Surgery (EACTS)
Mechanical Circulatory Support Summit that featured tecarfarin
historical data and Cadrenal's proposed clinical trial protocol to
evaluate tecarfarin versus warfarin in patients with the Abbott
HeartMate3 (HM3) left ventricular assist device (LVAD).
The presentation, titled Tecarfarin and
Hemocompatibility with LVAD Therapy (TECH-LVAD), took
place in Prague, Czech Republic
and outlined Cadrenal's proposed clinical trial protocol recently
submitted to the U.S. Food and Drug (FDA). Dr. Mandeep R. Mehra, who holds the William Harvey
Chair in Advanced Cardiovascular Medicine and is Executive
Director, Center for Advanced Heart Disease, Brigham and Women's
Hospital, developed and delivered the TECH-LVAD presentation. In
the presentation Dr. Mehra highlighted data from past trials
demonstrating the inverse relationship between bleeding rates and
time in therapeutic range (TTR) for HM3 patients, and evidence from
prior studies indicating tecarfarin's potential ability to improve
TTR. He included data from a trial in end-stage kidney disease
(ESKD) patients showing that ESKD does not alter tecarfarin
exposure while warfarin exposure is increased, explaining that this
is one of the critical differentiators for tecarfarin because many
LVAD patients have kidney impairment.
Dr. Mehra, who also chaired Abbott's ARIES-HM3 study in LVAD
patients and is a Professor of Medicine, Harvard University, commented, "In the proposed
TECH-LVAD trial, we plan to study a much-needed VKA option with the
expectation of reducing bleeding events that accompany use of the
HM3 LVAD in advanced heart failure. Tecarfarin could potentially be
an important therapy for patients with LVADs who all require
chronic anticoagulation."
"As our team progresses discussions with the FDA and Abbott
about a tecarfarin study in LVAD patients, increasing tecarfarin
data visibility will help us to continue accelerating our
development as we plan for investigator outreach and patient
recruitment for our tecarfarin trial," said Quang X. Pham, Chief Executive Officer of
Cadrenal Therapeutics.
ABOUT CADRENAL THERAPEUTICS, INC.
Cadrenal Therapeutics is a late-stage biopharmaceutical company
developing tecarfarin, a new vitamin K antagonist (VKA) designed to
offer safer, more effective chronic anticoagulation for patients
with implanted cardiac devices or rare cardiovascular conditions.
Tecarfarin is anticipated to result in fewer adverse events such as
strokes, heart attacks, bleeds, and deaths than warfarin, the most
commonly used anticoagulant for these patients, despite its
prevalent adverse events, drug-to-drug interactions, and frequent
dosing changes. Cadrenal is focused on evaluating tecarfarin's
superiority to warfarin in these patients where direct oral
anticoagulants (DOACs) are not recommended in the treatment
guidelines of leading cardiology associations. Tecarfarin received
an orphan drug designation for advanced heart failure patients with
implanted left ventricular assist devices (LVADs) as well as both
orphan drug and fast-track status for end-stage kidney disease
patients with atrial fibrillation. Cadrenal is opportunistically
planning pivotal clinical trials and pursuing clinical and
commercial partnerships to advance tecarfarin. The company's plans
also include studying tecarfarin in patients with mechanical heart
valves experiencing anticoagulation difficulties.
Visit www.cadrenal.com to learn more.
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 our planned pivotal trial to evaluate tecarfarin's
effectiveness for LVAD patients, tecarfarin's potential ability to
improve TTR; the plan to study a much-needed VKA option with
the expectation to reduce bleeding events that accompany use of the
HM3 LVAD in advanced heart failure; tecarfarin potentially being an
important therapy for patients with LVADs who all require chronic
anticoagulation and advancing the visibility of tecarfarin data
helping to continue to accelerate the Company's development as it
plans for investigator outreach and patient recruitment for its
tecarfarin trial. 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 TTR and anticoagulation treatment
in patients, the ability of the Company to advance tecarfarin with
patients with left ventricular assist devices (LVADs) and
those with ESKD with AFib, the collaborative efforts with
Abbott being successful 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 Securities and Exchange Commission, 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.