Cadrenal Therapeutics Highlights High Incidence of Thrombotic Complications in Heparin-Induced Thrombocytopenia (HIT) at the J.P. Morgan Healthcare Conference and VLX-1005 as a Potential Therapeutic Solution as the First and Only Selective 12-LOX Inhibitor

Core Insights - Cadrenal Therapeutics is addressing the unmet medical need in heparin-induced thrombocytopenia (HIT) with its investigational drug candidate VLX-1005, which is the first and only potent, highly selective 12-LOX inhibitor in clinical testing [1][3][10] Company Developments - Cadrenal acquired VLX-1005 in December 2025, recognizing its potential to transform treatment for HIT and other immune-mediated thrombotic disorders [2] - The company is rapidly engaging with the U.S. Food and Drug Administration (FDA) to discuss the design of a potential pivotal Phase 3 registration study for VLX-1005 in HIT [9] Clinical Insights - Emerging data from a Phase 2 clinical trial suggest that VLX-1005 may reduce thrombotic complications, indicating its potential as a novel therapy that targets immune thrombotic drivers rather than just suppressing coagulation [3][4] - Recent findings highlight the high incidence and clinical burden of thrombotic complications in HIT, emphasizing the limitations of existing therapies that do not directly modulate platelet immune responses [5] Scientific Background - 12-lipoxygenase (12-LOX) has been identified as a key mediator of platelet activation and immune thrombotic responses, making it a compelling therapeutic target [6] - VLX-1005 is designed to selectively modulate immune-mediated platelet activation while minimizing off-target effects, representing a significant advancement in the development of 12-LOX inhibitors [8] Regulatory Status - VLX-1005 has received Orphan Drug Designation (ODD) and Fast Track designation from the FDA, as well as orphan drug status from the European Medicines Agency [10]