VarmX has enrolled the first participant in its global phase 3 EquilibriX S trial evaluating VMX C001 for restoring normal coagulation in patients taking FXa inhibitors who require an urgent surgery or procedure.
The randomised controlled study will recruit participants across more than 20 countries. It will assess whether a single intravenous dose of VMX C001 can rapidly and reliably restore hemostasis in patients who have received an FXa inhibitor within the previous 15 hours. The primary endpoint is the proportion of participants achieving good or excellent hemostatic efficacy. Safety outcomes will also be measured.
VMX C001 is a recombinant modified human coagulation Factor X protein engineered to be insensitive to Factor Xa inhibitors. It is designed to bypass their anticoagulant activity and support restoration of the coagulation cascade.
Its potential advantages include fixed-dose administration regardless of the FXa inhibitor used and rapid IV delivery. It also preserves common anticoagulants such as heparin and is being evaluated for a minimized thrombotic risk profile.
John Glasspool, Chief Executive Officer of VarmX, commented: “Enrolling the first participant in EquilibriX S marks a significant milestone for VarmX and for the millions of patients taking Factor Xa inhibitors who may one day need an urgent surgery or procedure. VMX C001 has shown the potential to restore coagulation regardless of which FXa inhibitor a patient is taking, and this phase 3 trial will provide the pivotal data needed for regulatory approval.”
By 2030, around 30 million patients in the U.S., Europe and Japan are expected to receive FXa inhibitors as chronic anticoagulation therapy.
More than 30,000 of these patients each week experience severe life-threatening bleeding or require emergency surgery, where bleeding risk presents a critical challenge*.
