PONTE
VEDRA, Fla., March 30,
2023 /PRNewswire/ -- Cadrenal Therapeutics,
Inc., (Nasdaq: CVKD) a biopharmaceutical company focused on
developing tecarfarin, a late-stage novel cardiorenal therapy with
orphan drug and Fast Track designations, today provided a corporate
update in connection with the filing of its Annual Report on Form
10-K for the year ended December 31,
2022.
Recent Highlights
- U.S. Food and Drug Administration ("FDA") granted Fast Track
designation for tecarfarin for the prevention of systemic
thromboembolism of cardiac origin in patients with end-stage renal
disease and atrial fibrillation.
- Formed Scientific Advisory Board (SAB) in support of the
development of tecarfarin for the prevention of systemic
thromboembolism.
- Appointed Douglas Losordo as
Chief Medical Officer, and Matthew
Szot as Chief Financial Officer.
- Rang the Nasdaq closing bell on February
8, 2023.
- Completed an initial public offering ("IPO") raising gross
proceeds of $7.0 million with the
listing of its common shares on the Nasdaq Capital Market.
"Over the past year, we have taken significant steps to advance
the development of tecarfarin, a novel therapy designed for the
prevention of blood clots of cardiac origin in patients with
end-stage renal disease and atrial fibrillation," commented
Quang Pham, CEO of Cadrenal
Therapeutics. "Following our acquisition of the rights to
tecarfarin in April 2022, we moved
quickly to assemble a world-class group of anticoagulant, medical
and scientific experts to provide strategic guidance to Cadrenal,
and brought on key management team members to advance our mission.
Earlier this year, we successfully received Fast Track designation
from the U.S. FDA for tecarfarin and completed our initial public
offering. We are currently planning a Phase 3 clinical trial for
tecarfarin based on feedback previously received by the U.S. FDA.
We look forward to working closely with the FDA to evaluate this
therapy as a potential new treatment option for the severely
underserved patient population that has end-stage renal disease and
atrial fibrillation."
Tecarfarin
Tecarfarin, which has been granted orphan drug and Fast Track
designations by the U.S. FDA, for the prevention of systemic
thromboembolism (blood clots) of cardiac origin in patients with
End-Stage Renal Disease (ESRD) and Atrial Fibrillation (AFib), 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 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. Cadrenal secured the rights
to tecarfarin on April 1, 2022 via an
asset purchase agreement. Approximately $90
million has been invested to date in clinical and regulatory
work by previous owners of tecarfarin.
Cadrenal believes its Phase 3 will be the remaining pivotal
trial. The Phase 3 trial, called Anti-Coagulation with Tecarfarin
on Outcomes in Renal disease and AFib (ACTOR-AF) is designed as a
Phase 3, 492-patient, randomized, double-blind, placebo-controlled
outcomes study of tecarfarin vs. placebo in subjects with ESRD and
AFib not currently treated with chronic oral anticoagulation.
Dr. Douglas Losordo, Chief
Medical Officer of Cadrenal, commented, "It is a unique opportunity
to have a late-stage cardiovascular drug with only one expected
remaining pivotal trial remaining until NDA submission. We look
forward to advancing the Phase 3 ACTOR-AF trial with the goal of
providing a stroke prevention therapy to a high-risk population
with no current proven treatment options."
Market Opportunity
The presence of either chronic kidney disease (CKD) or AFib
increases the risk of serious thromboembolic adverse clinical
outcomes, such as stroke and death. AFib increases the risk of
stroke by 5 times and is the most common arrhythmia. ESRD further
doubles the risk of stroke. Antithrombotic therapy is typically
recommended to decrease this risk in AFib patients, but there are
no therapies for patients that have ESRD with AFib that have been
proven to lower the risk of stroke.
Overall, 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 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 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 disease contributes to more than
half of all deaths among patients with ESRD.
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.
Based upon a 2019 study, adjusted for inflation, the U.S. market
potential for tecarfarin is estimated up to $1 billion annually if approved by the FDA.
Pham continued, "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 a high morbidity rates and
exorbitant costs to the American healthcare system due to lack of
effective treatment."
Orphan Drug and Fast Track Designations
The FDA has granted tecarfarin both orphan drug designation
(ODD) and Fast Track designation to tecarfarin for the prevention
of systemic thromboembolism, more commonly referred to as blood
clots, of cardiac origin in patients with ESRD and AFib.
The FDA grants ODD status to drugs that are intended for the
treatment, diagnosis, or prevention of rare diseases or conditions,
which are defined as a disease or condition that affects fewer than
200,000 people in the U.S. The ODD program provides a drug
developer with certain benefits and incentives, including a
seven-year period of U.S. marketing exclusivity from the date of
marketing authorization, waiver of FDA user fees, and tax credits
for clinical research.
Fast Track is a process designed to facilitate the development
and expedite the review of drugs to treat serious conditions and
fill an unmet medical need. The purpose of Fast Track is to get
important new drugs to the patient earlier. Fast Track addresses a
broad range of serious conditions.
Scientific Advisory Board
"Cadrenal is fortunate to have engaged thought leaders in the
key disciplines involved in our tecarfarin program. We look forward
to their guidance as we advance this program to completion,"
continued Dr. Losordo.
Please click here to view the Company's Scientific Advisory
Board.
Corporate Slide Presentation
Cadrenal recently posted a corporate slide presentation on its
website. To view the presentation, please visit:
https://www.cadrenal.com/investors/.
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 (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 CKD. 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 as
a potential new treatment option for the severely underserved
patient population that has end-stage renal disease and atrial
fibrillation, 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, tecarfarin having one expected pivotal trial
remaining until NDA submission and tecarfarin being the
answer for patients with either chronic kidney disease or
AFib. 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 and the Company's future filings with the Securities
and Exchange Commission. 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.