CSL (ASX:CSL) has announced a deal with Dutch biotech VarmX to advance a new therapy designed to restore blood clotting in patients taking Factor Xa (FXa) inhibitors, a widely prescribed class of anticoagulants.
Globally, more than 20 million people are on FXa inhibitors for chronic anticoagulation therapy. While highly effective, these medicines carry risks. Around 3 per cent of patients experience severe bleeding or require urgent surgery.
VarmX’s candidate, VMX-C001, is a recombinant Factor X protein developed to bypass the anticoagulant activity and rapidly restore coagulation. It is intended to be delivered as a single-dose infusion and could become the first treatment of its kind.
CSL Chief Executive Officer Paul McKenzie said the partnership reflects the company’s strategic focus on hematology and its growing appetite for external collaborations. “This new treatment will potentially address a clear and significant unmet medical need in a well-defined and growing patient population,” he said. “It also fits with our strategy of seeking more external partners to help accelerate our clinical and commercial pipeline.”
The promise of VMX-C001 has already been recognised by the US Food and Drug Administration, which granted the therapy Fast Track Designation after reviewing early preclinical and clinical data.
Under the terms of the agreement, CSL will fund a global Phase 3 trial of VMX-C001 in patients on FXa inhibitors, and provide late-stage development, manufacturing, and pre-commercialisation support. CSL has also secured an exclusive option to acquire VarmX, paying US$117 million upfront. If the option is exercised following Phase 3 results, VarmX could receive up to US$388 million in milestone payments through to launch, with additional payments linked to commercial success.
If trials progress as planned, CSL and VarmX anticipate a commercial launch of VMX-C001 in 2029, opening a potential new treatment frontier for patients facing life-threatening bleeding while on modern blood-thinning therapies.