VarmX, a biotech company developing innovative approaches to bypass direct oral anticoagulants targeting activated factor Xa (FXa inhibitors), enrolled the first participant in its global phase 3 EquilibriX-S trial. The trial is evaluating VarmX’s lead asset, VMX‑C001, for the rapid restoration of normal coagulation in patients taking any FXa inhibitor who require an urgent surgery/procedure.
EquilibriX‑S is a randomised, controlled phase 3 study enrolling participants across more than 20 countries. The trial will examine whether a single intravenous dose of VMX‑C001 can reliably and quickly restore hemostasis during urgent surgical procedures in participants receiving FXa inhibitors within the previous 15 hours. The primary endpoint is the proportion of participants achieving good or excellent hemostatic efficacy, with safety endpoints also being evaluated.
VMX-C001 is a recombinant modified human coagulation Factor X protein engineered to be insensitive to Factor Xa inhibitors, designed to bypass their anticoagulant activity and support restoration of the coagulation cascade. VMX-C001’s potential advantages in addition to coagulation restoration include fixed-dose administration regardless of the specific FXa inhibitor used, rapid IV delivery, preservation of common anticoagulants, such as heparin, and a minimised thrombotic risk profile. These properties are being evaluated as part of the ongoing pivotal phase 3 clinical trial EquilibriX-S, with the aim of establishing VMX-C001 as a treatment option for patients on FXa inhibitors requiring emergency surgery.
By 2030, approximately 30 million patients in the US, Europe and Japan are expected to receive FXa inhibitors as a chronic anticoagulation therapy, including stroke prevention in atrial fibrillation and the prevention of deep vein thrombosis. Each week, more than 30,000 of these patients experience severe life-threatening bleeding or require emergency surgery, where the risk of bleeding poses a critical challenge.
