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NASDAQ:CVKD
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Business Update
Cadrenal Therapeutics, Inc. (NASDAQ:CVKD) is a biopharmaceutical company developing tecarfarin, a late-stage novel oral and reversible anticoagulant intended to prevent heart attacks, stroke, and death due to blood clots in patients suffering from rare cardiovascular conditions requiring chronic anticoagulation. These conditions include patients with left ventricular assist devices (LVADs), patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib), and patients with mechanical heart valves with difficult-to-control time in therapeutic range (TTR). We recently initiated on Cadrenal and for a full overview of the company we invite investors to read through our full initiation report here . Some highlights about why we believe Cadrenal is an exciting investment opportunity include:
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Solving Warfarin’s Major Problems – Warfarin is a vitamin K antagonist (VKA) treatment option that has been used for thrombosis since the 1950’s. However, there are many adverse events associated with warfarin’s use, including bleeding, skin necrosis, and hair loss. In addition, there are many drug-drug interactions due to its metabolic profile. Tecarfarin is a VKA that was designed to solve the warfarin metabolism problem and is also not impacted by kidney function.
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Metabolic Advantage Sets Tecarfarin Apart – Tecarfarin is metabolized via an alternative pathway (Carboxylesterase 2, CES2) that is abundant and essentially unsaturable. Warfarin is metabolized by seven different CYP450 isoenzymes, with approximately 30% of the population harboring genetic variants of CYP2C9 that alters warfarin metabolism. In addition, warfarin metabolism is further complicated by inhibitors and inducers of CYP450 enzymes that directly impacts its activity.
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Phase 3 Ready Asset – Cadrenal has designed a randomized, single blind, Phase 3, multicenter study to evaluate tecarfarin compared to warfarin in patients with LVADs. The company is continuing discussions with the FDA regarding the finalized Phase 3 protocol and we anticipate an update in the first half of 2025. Cadrenal is also in discussions with Abbott, the maker of the only approved LVAD device in the U.S., on a potential collaboration for the Phase 3 trial.
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ODD for LVADs and ESKD+Afib – The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to tecarfarin for the prevention of thrombosis in patients with LVADS and ODD and Fast Track status to tecarfarin for the prevention of systemic thromboembolism of cardiac patients with ESKD and AFib. ODD provides an approved drug with a seven-year period of U.S. marketing exclusivity along with other benefits and incentives. Fast Track is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need and could result in priority review of the New Drug Application (NDA).