Cadrenal Therapeutics completes CAD-1005 End-of-Phase 2 meeting with FDA

Cadrenal Therapeutics (CVKD) announced a regulatory milestone after completing its End-of-Phase 2 meeting with the FDA and receiving guidance on key elements of the Phase 3 pivotal trial for CAD-1005, the company’s investigational first-in-class 12-lipoxygenase inhibitor for heparin-induced thrombocytopenia. The meeting with the FDA provided critical guidance on protocol design, study population, dosing, background therapy, exposure, the safety database, and the primary endpoint of new or worsening thrombotic events. After considering FDA feedback on a pivotal registration study, Cadrenal plans to advance directly to a randomized, blinded, placebo-controlled Phase 3 study evaluating CAD-1005 added to the current standard of care for patients with HIT.