Cadrenal's CAD-1005 Shows Thrombotic Event Reduction in HIT Trial — Cadrenal Therapeutics, Inc.

Event summary

Phase 2 trial of CAD-1005 in HIT patients showed >25% absolute reduction in thrombotic events vs. placebo.
Primary endpoint (platelet count recovery) not met, but secondary endpoint (thrombotic events) showed encouraging results.
End-of-Phase 2 meeting with FDA scheduled for March 2026 to align on Phase 3 registration path.
Study included 24 patients, randomized to CAD-1005 or placebo, all receiving standard anticoagulant therapy.

The big picture

Cadrenal Therapeutics is advancing a novel approach to treating heparin-induced thrombocytopenia (HIT) with CAD-1005, a selective inhibitor of 12-lipoxygenase. The Phase 2 results suggest that targeting the immune mechanisms underlying HIT could be more effective than standard anticoagulant therapy alone. This positions Cadrenal at the forefront of developing therapies for life-threatening immune and thrombotic conditions, addressing a significant unmet medical need in a market where heparin is widely used but complications like HIT remain severe.

What we're watching

Regulatory Pathway: Whether the FDA will accept the secondary endpoint data as sufficient for Phase 3 advancement.
Clinical Validation: The pace at which additional data can confirm CAD-1005's efficacy in larger patient populations.
Competitive Positioning: How Cadrenal differentiates CAD-1005 as the only 12-LOX inhibitor targeting HIT's immune mechanisms.

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