Biotech company VarmX has received clearance from the US FDA to begin a phase 3 trial of its lead candidate, VMX-C001, in patients requiring urgent surgery while on factor Xa direct oral anticoagulants (FXa DOACs).
The decision enables the launch of the global EquilibriX-S trial later this year, spanning more than 20 countries. The study will evaluate how effectively VMX-C001 restores blood clotting in emergency surgical settings.
VMX-C001 is a modified human factor X protein engineered to bypass the effects of FXa DOACs. It acts by restoring the coagulation process quickly and safely, offering advantages such as universal dosing, ease of administration and compatibility with existing anticoagulants like heparin.
Crucially, the treatment does not increase thrombotic risk, a key concern in managing emergency bleeding scenarios. VarmX sees the therapy as addressing a major unmet medical need, with no current approved treatments for this situation.
By 2030, an estimated 25 million patients in the US and Europe will be on FXa DOACs for long-term conditions including atrial fibrillation and deep vein thrombosis. Each week, around 25,000 of these individuals require emergency surgery or suffer life-threatening bleeding.
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.”
