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Cadrenal Therapeutics Announces End-of-Phase 2 Meeting with the FDA and Pivotal Phase 3 Registration Path for CAD-1005 in Heparin-Induced Thrombocytopenia (HIT)

CVKD
  • Cadrenal Therapeutics completed an End-of-Phase 2 meeting with the FDA to receive critical guidance for advancing CAD-1005 to a pivotal Phase 3 trial for heparin-induced thrombocytopenia (HIT).
  • Phase 2 data demonstrated a greater than 25% absolute reduction in thrombotic events when CAD-1005 was added to standard anticoagulant therapy.
  • The planned Phase 3 study will be a randomized, blinded, placebo-controlled trial evaluating CAD-1005 added to standard care in approximately 120 patients across up to 50 global clinical centers.
  • Patients with suspected HIT will receive CAD-1005 or placebo alongside standard anticoagulant therapy for up to 14 days during hospitalization.
  • The primary endpoint is the incidence of new or worsening thrombotic events in Serotonin Release Assay (SRA)-confirmed HIT patients, with at least one interim analysis planned.
  • Cadrenal aims to submit a New Drug Application (NDA) in 2029 based on the results of this pivotal trial.
  • CAD-1005 is a first-in-class 12-LOX inhibitor designed to target the underlying immune mechanisms of HIT, distinct from current therapies that only prevent complications.
  • The investigational drug has received Orphan Drug Designation, Fast Track designation from the FDA, and orphan drug status from the European Medicines Agency.
  • HIT affects over 12 million U.S. patients annually who receive heparin, carrying mortality rates exceeding 20% in some studies.
  • CAD-1005 is the only treatment in clinical development that targets the primary immune drivers of HIT.