Tecarfarin, a novel therapy designed for
the prevention of systemic thromboembolism (blood clots) of cardiac
origin in patients with End Stage Renal Disease and Atrial
Fibrillation, may be a new treatment option for this underserved
patient population
PONTE
VEDRA, Fla., March 9,
2023 /PRNewswire/ -- Cadrenal Therapeutics,
Inc., (Nasdaq: CVKD) a biopharmaceutical company focused on
developing tecarfarin, a clinical-stage novel cardiorenal therapy
with orphan drug and Fast Track designations, recognizes National
Kidney Month throughout the month of March as it advances
tecarfarin for a severely underserved subset of the overall kidney
disease population.
Overall, Chronic Kidney Disease (CKD) affects almost 40 million
American adults, with as many as 90% of Americans who have CKD not
knowing they have the disease until it is very advanced. A more
dire subset is the more than 800,000 Americans with End-Stage Renal
Disease (ESRD), or permanent kidney failure that requires life-long
dialysis or a kidney transplant. Nearly 20% of ESRD patients, or
150,000 individuals, also have Atrial Fibrillation (AFib) or an
irregular heartbeat, which nearly doubles the anticipated mortality
and increases the stroke risk by approximately five-fold in these
patients. There is evidence that AFib is an independent risk factor
for developing ESRD in CKD patients. Both diseases share common
risk factors including hypertension, diabetes, vascular disease,
and advancing age. Cardiovascular diseases contribute to more than
half of all deaths among patients with ESRD.
Cadrenal is developing tecarfarin, a novel therapy which has
been granted and orphan drug and Fast Track designations by the US
FDA for the prevention of systemic thromboembolism (blood clots) of
cardiac origin in patients with ESRD and AFib.
According to the Annual Data Report published by the United
States Renal Data System, total Medicare spending for patients with
ESRD reached $51 billion in 2019,
accounting for approximately 7% of the Medicare paid claims
costs.
Quang Pham, Founder and CEO of
Cadrenal Therapeutics, commented, "The presence of either chronic
kidney disease or AFib increases the risk of serious thromboembolic
adverse clinical outcomes, such as stroke and death. Antithrombotic
therapy is typically recommended to decrease this risk in AFib
patients, but unfortunately, there are no approved therapies for
patients that have ESRD with AFib. Cadrenal hopes tecarfarin can be
the answer for this group of patients which carry high morbidity
rates and exorbitant costs to the American healthcare system due to
lack of effective treatment."
Tecarfarin is a Vitamin K antagonist oral anticoagulant
specifically designed to leverage the advantages of one of the most
prescribed anticoagulant drugs used in the treatment of
thrombosis and AFib, warfarin, while avoiding its
pitfalls.
"We are currently planning a Phase 3 clinical trial for
tecarfarin based on feedback previously received by the FDA. We
look forward to working closely with the FDA to evaluate this
therapy as a potential new treatment option for this severely
underserved patient population," Pham continued.
Patients with ESRD and AFib are at high risk for adverse
outcomes and therefore these patients have typically been excluded
from previous randomized pivotal clinical trials, including studies
of anticoagulants that are widely prescribed to prevent
stroke.
Based on its more stable metabolism, tecarfarin could fill this
gap and provide ESRD patients with an option to reduce the
increased stroke risk resulting from AFib that does not presently
exist for these patients.
For more information on tecarfarin or the ACTOR-AF Phase 3
clinical trial, please contact the Company at
press@cadrenal.com.
ABOUT CADRENAL THERAPEUTICS, INC.
Cadrenal Therapeutics is focused on developing tecarfarin, a
novel cardiorenal therapy with orphan drug and Fast Track
designations for the prevention of systemic thromboembolism (blood
clots) of cardiac origin in patients with end-stage renal disease,
or ESRD, and atrial fibrillation (irregular heartbeat), or AFib.
Tecarfarin is a Vitamin K antagonist oral anticoagulant designed to
target a different pathway than the most commonly prescribed drugs
used in the treatment of thrombosis and AFib. Tecarfarin has been
evaluated in eleven 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 planning a Phase 3 clinical trial for tecarfarin based on
feedback previously received by the U.S. FDA, working closely with
the FDA to evaluate this therapy as a potential new treatment
option for this severely underserved patient population and
tecarfarin providing ESRD patients with an option to reduce the
increased stroke risk resulting from AFib that does not presently
exist for these 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 to advance the program to completion, the ability to
advance patient care in cardiorenal diseases and the other factors
discussed in the "Risk Factors" section of the initial public
offering prospectus filed with the SEC. Any forward-looking
statements contained in this press release speak only as of the
date hereof and, except as required by federal securities laws,
Cadrenal Therapeutics 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.