• Enables initiation of global EquilibriX-S trial later this year
  
  
• Critical milestone in development of novel bypass agent to restore coagulation, enabling urgent surgery in patients taking any Factor Xa Direct Oral Anticoagulants (FXa-DOACs)

Leiden, The Netherlands, 8 July 2025 – VarmX, a biotech company developing innovative approaches for the bypass of direct oral anticoagulants targeting activated factor Xa (FXa DOACs) and inherited coagulation disorders, announces that the U.S. FDA has cleared the Investigational New Drug (IND) application for its lead asset VMX-C001, enabling the initiation of EquilibriX-S, a global Phase 3 trial in Urgent Surgery.

EquilibriX-S is a landmark clinical trial evaluating the ability of a FXa DOAC bypassing agent to rapidly and durably restore coagulation in patients taking any FXa DOAC undergoing urgent surgery, with planned enrollment in over 20 countries.

VMX-C001 is a modified, human, factor X protein, designed to be insensitive to FXa DOACS, effectively bypassing their anticoagulant activity and swiftly restoring the coagulation cascade.VMX-C001 has been developed with significant clinical advantages, including universal dosing regardless of the specific FXa DOAC used, rapid and easy administration, compatibility with commonly anticoagulants like heparin, and crucially, no additional thrombotic risk.

By 2030, approximately 25 million patients in the US and Europe will be treated with FXa DOACs for chronic anticoagulation therapy, including stroke prevention in atrial fibrillation and the prevention of deep vein thrombosis. Each week, around 25,000 of these patients experience severe life-threatening bleeding or require emergency surgery, where the risk of bleeding poses a critical challenge.

John Glasspool, CEO of VarmX, said: 

“The IND clearance for VMX-C001 marks a major milestone in advancing our novel bypass agent, designed to rapidly restore coagulation to enable urgent surgery in patients on Factor Xa direct oral anticoagulants — an area with no approved treatments today. We are now forging ahead with plans to initiate our Phase 3 trial later this year.