
March 02, 2026
Encouraging data for CAD-1005 in Phase 2 HIT Study
EOP2 scheduled for Q1 for top-priority indication
Additional acute and chronic opportunities for 12-LOX inhibition beyond HIT
PONTE VEDRA, Fla., March 02, 2026 (GLOBE NEWSWIRE) -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company developing therapies for life-threatening immune and thrombotic disorders, today provided additional perspectives on development opportunities following its recent pipeline expansion with the addition of 12-LOX inhibitors.
As previously announced, Cadrenal recently acquired a portfolio of selective 12-LOX inhibitors, including oral candidates. Encouraging recent data from a blinded, placebo-controlled Phase 2 study of CAD-1005, a parenteral 12-LOX inhibitor, in heparin-induced thrombocytopenia (HIT) demonstrated a reduction in thrombotic events on a background of standard anticoagulants, with an End-of-Phase 2 (EOP-2) meeting scheduled for later this month.
While HIT remains Cadrenal’s near-term regulatory priority with CAD-1005, an ever-growing body of scientific research supports the central role that 12-LOX also plays in inflammatory signaling across multiple high-impact disease areas. Published studies have highlighted its role in atherosclerosis and vascular inflammation, microvascular thrombosis, ischemia-reperfusion injury, and immune-mediated metabolic conditions, including beta-cell stress pathways associated with type 1 diabetes and obesity.
Collectively, these therapeutic areas represent multi-billion-dollar potential global markets and opportunities to address novel pathways and potentially improve otherwise poor patient outcomes. Cadrenal’s new 12-LOX inhibitor portfolio is a differentiated platform approach across a range of thrombotic and inflammatory conditions, with both acute and chronic potential applications.
“We are very excited to have the only selective 12-LOX inhibitor currently in clinical-stage development and continue to move forward with HIT as our lead indication and regulatory priority,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. “We also appreciate that 12-LOX inhibition represents an entirely new – and exciting - therapeutic approach and are optimistic that safely and selectively targeting 12-LOX can have far-reaching therapeutic implications in multiple disease areas.”
Lipoxygenases are a family of enzymes involved in lipid metabolism that stimulate the incorporation of oxygen into polyunsaturated fatty acids. The enzymatic action of 12-LOX ultimately leads to the formation of 12-HETE, a lipid molecule that easily crosses cell membranes. Intracellularly, 12-HETE promotes oxidative stress, while extracellularly, 12-HETE modulates a variety of signaling pathways to regulate inflammatory activity and elicit pro-inflammatory effects. In human blood, 12-LOX is found primarily in platelets and leukocytes; it is also found within the pancreas of diabetics and in certain cancer cells. In HIT, 12-LOX is a critical link in platelet activation via the IgG receptor. Early attempts to develop 12-LOX inhibitors failed because they were not 12-LOX specific. CAD-1005 is the first successful selective 12-LOX inhibitor and the only one to advance to clinical-stage development.
CAD-1005 is an investigational therapy being evaluated for the treatment of suspected HIT. CAD-1005 is designed to selectively inhibit 12-LOX, a pathway integral to the primary immune mechanisms driving HIT. Unlike existing therapies for HIT, which are only directed at preventing thrombotic complications, this approach addresses the primary underlying cause of HIT. In preclinical models of HIT, CAD-1005 has been shown to prevent or treat HIT and halt the development of both thrombocytopenia and blood clots. The drug has not been associated with increased bleeding in animals or healthy human volunteers. CAD-1005 has received Orphan Drug Designation (ODD) and Fast Track designation from the U.S. Food and Drug Administration and orphan drug status from the European Medicines Agency.
Cadrenal Therapeutics, Inc. (Nasdaq: CVKD) is a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions. Its lead program, CAD-1005, is a first-in-class 12-LOX inhibitor for the treatment of heparin-induced thrombocytopenia (HIT), a deadly immune-mediated thrombotic disorder. CAD-1005 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration, as well as orphan drug status from the European Medicines Agency. Second-generation 12-LOX oral therapeutics are also under development.
The Company’s broader pipeline includes tecarfarin, a Phase 3-ready oral vitamin K antagonist for the treatment of patients with end-stage kidney disease and those with left ventricular assist devices, and frunexian, a parenteral, clinical-stage Factor XIa inhibitor designed for use in acute hospital settings. For more information,
visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.
Any statements 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.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “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. These statements include statements regarding advancing VLX-1005 for the treatment of HIT; continuing to advance novel therapeutics to treat or prevent thrombosis in high-risk patients; the emerging data from VLX-1005 suggesting meaningful potential to improve patient outcomes while maintaining a favorable safety profile; VLX-1005 being a compelling strategic addition to Cadrenal’s pipeline; the payment to Veralox of milestone payments contingent upon the achievement of certain future clinical and regulatory milestones as well as royalties on global sales of the acquired assets upon future commercialization; the structure and terms of the agreement enabling Cadrenal to allocate capital to advancing the clinical development of VLX-1005; and developing transformative therapeutics to overcome the limitations of current anticoagulation therapy. 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 clinical development of VLX-1005 for the treatment of HIT; the ability to continue to advance novel therapeutics to treat or prevent thrombosis in high-risk patients; the ability to successfully complete clinical trials on time and achieve desired results and benefits as expected; the ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.
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