Cadrenal Therapeutics Acquires Tecarfarin from Horizon
PONTE VEDRA, Florida – April 1, 2022 – Cadrenal Therapeutics, Inc. (“Cadrenal”) has acquired the rights to tecarfarin from Horizon Technology Finance Corporation (NASDAQ: HRZN) (“Horizon”), a leading specialty finance company that provides capital in the form of secured loans to venture capital backed companies in the technology, life science, healthcare information and services, and sustainability industries.
The new company is headed by Founder and Chief Executive Officer Quang Pham who has a continuous five-year history with tecarfarin development via previous tecarfarin Investigational New Drug Application (IND) sponsors.
Tecarfarin is a late-stage, novel Vitamin-K antagonist oral anticoagulant which targets a different pathway than the most commonly prescribed drugs used in the treatment of thrombosis and atrial fibrillation (irregular heartbeat) or AFib. Tecarfarin received orphan drug designation (ODD) for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage renal disease, or ESRD, and AFib.
The FDA grants orphan status to drugs that are intended for the safe and effective treatment, diagnosis, or prevention of rare diseases or disorders that affect 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. The granting of an Orphan Drug Designation does not alter the FDA’s regulatory requirements to establish safety and effectiveness of a drug through adequate and well-controlled studies to support approval and commercialization.
The presence of either chronic kidney disease (CKD) 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 there are no approved therapies for patients with ESRD and AFib. Patients with ESRD and AFib have typically been excluded from clinical trials because the approved therapies for AFib have metabolic profiles that may increase drug exposures thereby increasing the known risks and challenges in managing these patients.
“The intersection between ESRD and non-valvular AFib is complicated and not easily parsed,” comment Quang Pham. “Tecarfarin has the potential to fulfil the unmet need for this underserving group of patients.”
Financial terms for the acquisition of tecarfarin by Cadrenal from Horizon were not disclosed.
Cadrenal Therapeutics is focused on developing tecarfarin, a novel cardiorenal therapy with orphan drug designation 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 is Phase-3 ready and has been evaluated in eleven (11) human clinical trials and over 1,003 individuals. For more information, please visit: www.cadrenal.com.