Компания VarmX начала глобальные клинические испытания препарата для экстренной остановки кровотечения у пациентов на антикоагулянтах

VarmX has enrolled the first participant in its global phase 3 EquilibriX S trial evaluating VMX C001 for the rapid restoration of normal coagulation in patients taking FXa inhibitors who require urgent surgery or procedures. The study will recruit participants across more than 20 countries, with efficacy and safety endpoints supporting worldwide regulatory submissions. EquilibriX S is a randomised, controlled phase 3 trial assessing whether a single intravenous dose of VMX C001 can reliably and quickly restore hemostasis in participants who have received FXa inhibitors within the previous 15 hours. The primary endpoint is the proportion of participants achieving good or excellent hemostatic efficacy. Safety endpoints will also be evaluated. 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. Potential advantages 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 assessed in the ongoing pivotal phase 3 trial. John Glasspool, Chief Executive Officer of VarmX, said: “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.” He added: “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 US, Europe and Japan are expected to receive FXa inhibitors as chronic anticoagulation therapy. Each week, more than 30,000 of these patients experience severe life‑threatening bleeding or require emergency surgery.