Cadrenal Therapeutics reported that its Phase 2 study of CAD‑1005, a selective 12‑lipoxygenase inhibitor, achieved a more than 25% absolute reduction in thrombotic events compared with placebo in patients with heparin‑induced thrombocytopenia (HIT). The study, which enrolled 24 patients and concluded in December 2025, also showed no difference in platelet count recovery, the primary endpoint.
The randomized, double‑blind, placebo‑controlled trial was stopped early after 24 participants were enrolled, a decision made when the interim analysis revealed a clear signal in the secondary endpoint. While platelet recovery did not improve, the 25% reduction in new or worsening deep‑vein thrombosis, pulmonary embolism, and stroke represents a clinically meaningful safety benefit for a condition that affects up to 5% of patients exposed to heparin and carries a mortality rate that can approach 20%.
CEO Quang X. Pham said the results "support the decision to acquire and rapidly advance CAD‑1005," while Chief Medical Officer James Ferguson noted that the study demonstrated that "platelet count recovery was not an appropriate surrogate endpoint for clinical efficacy in a trial where standard therapy event rates were strikingly high." Cadrenal plans to hold an End‑of‑Phase‑2 meeting with the FDA in March 2026 to discuss a Phase‑3 registration strategy.
Investors reacted positively to the announcement, citing the encouraging secondary efficacy signal and the regulatory milestone of an FDA meeting. The unique positioning of CAD‑1005 as the only 12‑LOX inhibitor in clinical development for HIT, combined with orphan drug and fast‑track designations, has reinforced investor confidence in the drug’s potential to become the first first‑line therapy that targets the underlying immune mechanism of HIT.
HIT prevalence varies across studies, with estimates ranging from 0.1% to 5% of heparin‑exposed patients, and mortality rates reported between 2% and 20%. CAD‑1005’s mechanism—selective inhibition of 12‑lipoxygenase—offers a novel therapeutic approach that could reduce thrombotic complications without the need for alternative anticoagulation strategies. The drug’s orphan drug status in the U.S. and Europe, along with fast‑track designation, may accelerate its development timeline.
Cadrenal’s financial profile remains modest; the company’s recent statements indicate a weak financial health score and a quick burn rate, although it holds more cash than debt. The Phase‑2 results provide a critical data point that could justify additional investment and support the company’s ability to fund a Phase‑3 trial, but the need for substantial capital remains a key consideration for stakeholders.
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