Cadrenal Acquires VLX-1005 and Related Assets from Veralox
Cadrenal Therapeutics acquired VLX-1005 and related 12-lipoxygenase assets from Veralox Therapeutics. The acquisition adds a late-stage, first-in-class drug candidate targeting a critical immune signaling pathway to Cadrenal's pipeline. VLX-1005 is a novel small-molecule inhibitor of 12-LOX, a key pathway driving immune platelet-mediated inflammation and a contributor to the pathogenesis of Heparin-Induced Thrombocytopenia, or HIT. This potentially life-threatening complication can occur in up to 5% of patients exposed to heparin - the most commonly used parenteral anticoagulant - regardless of dose, schedule, or route of administration. An estimated 56,000 confirmed diagnoses in the United States occur each year. Mortality and thromboembolic event rates remain high despite currently available therapies. A recent Phase 2 study evaluated VLX-1005 in individuals with suspected HIT, and interim results demonstrated encouraging reductions in thromboembolic events. VLX-1005 has received Orphan Drug Designation and Fast Track designation from the FDA, as well as orphan drug status from the EMA. Veralox is eligible to receive upfront and milestone payments contingent on the achievement of specified future clinical and regulatory milestones. Additionally, Veralox will be entitled to royalties on global sales of the acquired assets upon future commercialization.
Trade with 70% Backtested Accuracy
Analyst Views on CVKD
No data
About CVKD
About the author
Cadrenal Advances Anticoagulation Pipeline, VLX-1005 Completes Phase 2 Trial
- Phase 2 Trial Progress: Cadrenal's anticoagulant drug VLX-1005 has completed its Phase 2 clinical trial, with data currently under analysis and expected to be published soon, indicating the company's potential in the anticoagulation sector despite a 4% drop in stock price prior to this announcement.
- FDA Fast Track Designation: VLX-1005 has received both Orphan Drug and Fast Track designations from the FDA, highlighting its potential market value in treating heparin-induced thrombocytopenia (HIT) and likely expediting subsequent regulatory approval processes.
- Market Demand Insight: Approximately 50,000 new HIT cases occur annually in the U.S., underscoring the urgent need for new therapies, with Cadrenal's product poised to fill gaps left by existing anticoagulants, particularly in the context of heparin use during cardiovascular surgeries.
- Other Development Programs: In addition to VLX-1005, Cadrenal is advancing Tecarfarin and Fruinexian, with the former targeting patients with end-stage kidney disease and the latter being a short-acting Factor XI inhibitor for cardiovascular surgery, demonstrating the company's diversified strategic approach in the anticoagulation field.
Cadrenal Acquires VLX-1005 to Strengthen Anticoagulation Pipeline
- Acquisition Strengthens Pipeline: Cadrenal Therapeutics' acquisition of VLX-1005 and related 12-LOX assets immediately enhances its pipeline, addressing a $40 billion anticoagulation market and approximately 56,000 annual HIT diagnoses.
- Optimistic Clinical Outlook: VLX-1005 demonstrated good tolerability in two Phase 1 studies with healthy participants, showing no deaths or serious adverse events, indicating promising potential for application in HIT patients.
- Significant Market Potential: The HIT market is projected to reach $1 billion in the US and EU, and the development of VLX-1005 will help improve patient outcomes, addressing urgent needs in high-risk populations.
- Strategic Investment Returns: The acquisition agreement includes milestone payments and royalties on global sales, ensuring Cadrenal can allocate capital to advance VLX-1005's clinical development, driving long-term growth for the company.
