Key Highlights

• The peer-reviewed study, published in Pharmaceutics (MDPI), describes the non-clinical safety pharmacology, toxicokinetics and pharmacodynamics of VMX-C001 in rats and cynomolgus monkeys

   

• Repeat intravenous dosing of VMX-C001 at doses up to 10 mg/kg for two weeks was well tolerated in both species; 10 mg/kg, the highest dose tested, was established as the no-observed-adverse-effect level (NOAEL)

   

• No VMX-C001-related respiratory or cardiovascular effects were observed, and markers of coagulation activation (D-dimer and thrombin-antithrombin complexes) showed no consistent increase

   

• VMX-C001 showed approximately dose-proportional kinetics with no accumulation after repeat dosing, and its toxicokinetic profile was not affected by co-administration of rivaroxaban

   

• VMX-C001 restored thrombin generation that had been suppressed by rivaroxaban in vivo, and supported thrombin generation in samples spiked with edoxaban ex vivo, consistent with its mechanism as a Factor Xa inhibitor-bypassing agent

Read the full article: Pharmaceutics 2026, 18(10), 1210; https://doi.org/10.3390/pharmaceutics18101210

Notes to Editors

About reltodecacog alfa (relto, 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. Its potential advantages include fixed-dose administration regardless of the specific FXa inhibitor used, rapid intravenous delivery, preservation of common anticoagulants such as heparin, and a minimised thrombotic risk profile. These properties are being evaluated in the ongoing pivotal Phase 3 trial EquilibriX-S. VMX-C001 has received U.S. FDA Fast Track Designation and a Phase 1 waiver from the Japanese PMDA.

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. VarmX has a strategic collaboration with CSL to fund the EquilibriX-S trial. For more information, please visit www.varmx.com.

For further information, please contact:

info@varmx.com