Pharmaceutical company CSL supports VarmX in a $2.2 billion transaction in the United States
The stock market for anticoagulant reversal drugs is poised for significant growth, with projections estimating its value to reach between US$2.25-3.0 billion by 2030, as reported by Valuates Reports and Grand View Research. This burgeoning market is attracting new players, with German start-up Emfret GmbH introducing a novel approach last year.
One of the key players in this market is Andexanet alfa, a recombinant decoy protein developed by Portola and marketed by AstraZeneca. Approved in both the United States and European Union, it is used for anticoagulant reversal. In the ANNEXA-4 study, haemostatic efficacy was reported in about 80% of cases for Andexanet alfa. However, its effect is short, and rebound anticoagulation and thrombotic events have limited its uptake.
VarmX is another company developing a novel drug called VMX-C001. This recombinant Factor X variant is designed to resist inhibition by direct Factor Xa anticoagulants. VMX-C001 has received Fast Track designation from the US FDA and is intended for use in patients on Factor Xa inhibitors who require urgent surgery or have uncontrolled bleeding. The planned Phase III trial for VMX-C001 will test the drug in patients receiving apixaban or rivaroxaban who require emergency surgery.
CSL will finance the pivotal development of VMX-C001, and has an option to acquire VarmX should the Phase III trial succeed. If Phase III results validate safety and efficacy, VMX-C001 could establish a differentiated role in this competitive class. The first enrolment for the Phase III trial is anticipated in 2026, with initial readouts projected for 2027.
Takeda is also contributing to the market with its Phase III trial for TAK-330, an optimized prothrombin complex concentrate. This trial is designed to compare haemostatic efficacy with standard PCC treatment. Enrolment for the TAK-330 trial began in 2024 and Takeda expects data in 2026. Hospitals are familiar with PCCs, but the approach is non-specific and carries a thrombosis risk.
No pivotal study has been announced for Ciraparantag (PER977), which completed Phase II trials in healthy volunteers exposed to edoxaban. Development timelines for Ciraparantag remain uncertain.
The new approach introduced by Emfret GmbH last year is not detailed in the available information. As the stock market for anticoagulant reversal drugs continues to grow and evolve, it will be interesting to see how Emfret's innovation fits into the competitive landscape.
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