Cadrenal Therapeutics Recognizes National Kidney Month with Goal to Advance Tecarfarin for Severely Underserved Patient Population

Rhea-AI Summary

Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical firm, is advancing tecarfarin, a new therapy aimed at preventing systemic thromboembolism in patients with End-Stage Renal Disease (ESRD) and Atrial Fibrillation (AFib). During March, recognized as National Kidney Month, the company highlights the urgent need for effective treatments for this underserved group, which includes over 150,000 ESRD patients also suffering from AFib. With total Medicare spending for ESRD patients hitting $51 billion in 2019, tecarfarin's potential to reduce risks of stroke and mortality is significant. Currently, a Phase 3 clinical trial is being planned as the FDA shows interest.

Positive

• Tecarfarin has received orphan drug and Fast Track designations from the FDA.
• More than 1,000 individuals have been evaluated in clinical trials for tecarfarin with generally good tolerance observed.

Negative

• No approved therapies exist for ESRD patients with AFib, creating a significant market gap.

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.

FAQ

What is tecarfarin and how does it help patients with ESRD?

Tecarfarin is a novel therapy designed to prevent blood clots in patients suffering from End-Stage Renal Disease (ESRD) and Atrial Fibrillation (AFib).

What is the significance of the National Kidney Month for Cadrenal Therapeutics?

Cadrenal Therapeutics recognizes National Kidney Month to emphasize the urgent need for effective treatments for kidney disease, particularly for underserved ESRD patients.

How many ESRD patients are also affected by Atrial Fibrillation?

Approximately 150,000 ESRD patients in the U.S. also have Atrial Fibrillation.

What are the FDA designations granted to tecarfarin?

Tecarfarin has been granted orphan drug and Fast Track designations by the FDA.

What are the current developments regarding tecarfarin?

Cadrenal is planning a Phase 3 clinical trial for tecarfarin, based on previous FDA feedback.