Cadrenal Therapeutics (Nasdaq: CVKD) announced that it has completed an End-of-Phase II meeting with the FDA for CAD-1005, its investigational 12-lipoxygenase inhibitor for heparin-induced thrombocytopenia, clearing a path to a pivotal Phase III trial after Phase II data showed a greater than 25% absolute reduction in thrombotic events when the drug was added to standard anticoagulant therapy.
The planned pivotal study is a randomized, blinded, placebo-controlled trial enrolling approximately 120 patients with suspected HIT across up to 50 clinical centers worldwide, with a primary endpoint of new or worsening thrombotic events in patients with Serotonin Release Assay-confirmed HIT. Cadrenal projects an NDA submission in 2029.
Phase II data showed that CAD-1005, added to standard-of-care anticoagulation, produced a greater than 25% absolute reduction in thrombotic events compared with anticoagulation alone. The press release does not disclose the full Phase II patient numbers, statistical confidence intervals, or secondary endpoint detail, so the magnitude and precision of that signal cannot be independently assessed from available data. No improvement in platelet count recovery was reported.
CAD-1005 (formerly VLX-1005) inhibits 12-LOX, an enzyme implicated in the immune-mediated platelet activation cascade that underlies HIT. That mechanism distinguishes it from the two agents currently available for HIT in the US — argatroban, a direct thrombin inhibitor approved by the FDA in 2000, and bivalirudin (Angiomax [bivalirudin]), whose FDA label covers HIT patients undergoing percutaneous coronary intervention. Both approved agents act downstream, blunting thrombin generation rather than interrupting the upstream antibody-driven platelet activation that initiates the condition. CAD-1005 is designed as an adjunct to anticoagulation rather than a replacement, positioning it to address the residual thrombotic risk that persists even with optimal anticoagulant management.