VarmX enrols first participant in global Phase 3 EquilibriX‑S trial
evaluating VMX‑C001 in urgent surgery
- First participant enrolled: EquilibriX‑S (NCT07288489), a landmark registrational Phase 3 study of VMX-C001 vs usual pharmacologic care in patients taking FXa inhibitors who require urgent surgery/procedures, has begun enrolment
- Global scope: Participants to be recruited across more than 20 countries; clinical efficacy and safety endpoints will support worldwide regulatory submissions
- Innovative therapy: VMX-C001 is a recombinant modified human coagulation Factor X protein developed to be insensitive to Factor Xa inhibitors, specifically designed for rapid fixed-dose IV administration and for minimizing additional thrombotic risk; both being assessed in ongoing clinical trials
Leiden, The Netherlands, 20 August 2026, 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 randomized, 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 minimized 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.
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. We are grateful to our dedicated team, investigators, clinical partners and our strategic collaborator, CSL, for their efforts in bringing this programme to patients.”
By 2030, approximately 30 million patients in the U.S., 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*.
* RBC and Cowen (2018–2024), Syneos Health Consulting (incl. Japan), and clinical literature
ENDS
Notes to Editors
About VarmX
VarmX was spun out from Leiden University Medical Center (LUMC), in 2016 by Professor Pieter Reitsma, a world leading expert in hemostasis and thrombosis. VarmX’s lead compound VMX-C001 is a modified recombinant blood factor X. The compound is being developed for the treatment of severe spontaneous bleeding and for the prevention of bleeding during urgent surgery in patients taking oral factor Xa inhibitors (FXa DOACs) as anticoagulation therapy. The Company is supported by a strong syndicate of investors including Sound Bioventures, EIC, EQT Life Sciences (formerly LSP), Inkef, Lundbeckfonden BioCapital, Ysios Capital, BioGeneration Ventures and InnovationQuarter. Most recently, VarmX signed a strategic collaboration with CSL to fund the EquilibriX-S trial. For more information, please visit www.varmx.com
For further information, please contact:
Vigo Consulting (media enquiries)
Rozi Morris/ Melanie Toyne Sewell
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VarmX@vigoconsulting.com
