Cadrenal Phase 2 HIT Trial Shows 25% Reduction in Thrombotic Events
Cadrenal Therapeutics reported Phase 2 data showing a 25% absolute reduction in thrombotic events with CAD-1005 versus placebo on top of standard anticoagulants in 24 HIT patients. An End-of-Phase 2 meeting with the FDA is set for March 2026 to align on a Phase 3 registration path.
1. Phase 2 Trial Results
In a randomized, blinded, placebo-controlled Phase 2 trial in 24 heparin-induced thrombocytopenia patients, CAD-1005 achieved a 50% thrombotic event rate versus over 75% in the placebo group, representing a 25% absolute reduction. Platelet count recovery rates were similar across both arms, invalidating it as a surrogate endpoint.
2. FDA End-of-Phase 2 Meeting
Cadrenal has secured an End-of-Phase 2 meeting with the U.S. Food and Drug Administration for March 2026 to discuss trial design, efficacy endpoints, and a registration path for Phase 3 evaluation of CAD-1005.
3. CAD-1005 Mechanism and Designations
CAD-1005 selectively inhibits 12-lipoxygenase to target the immune signaling pathways driving HIT. The therapy holds Orphan Drug and Fast Track designations and is the only clinical-stage 12-LOX inhibitor worldwide for this indication.