VarmX, a biotechnology firm specializing in solutions for anticoagulation reversal, has obtained Investigational New Drug (IND) approval to advance its lead candidate, VMX‑C001, into a pivotal Phase 3 clinical trial. The study will investigate the effectiveness of a single dose in rapidly reversing Factor Xa (FXa) inhibitor effects in patients needing urgent surgical intervention.
VMX‑C001 is a modified recombinant human factor X specifically engineered to bypass FXa direct oral anticoagulants (DOACs), swiftly restoring normal blood coagulation. The upcoming trial, supported by regulatory bodies in both the U.S. and Europe, marks the next major stage following earlier clinical success. In Phase 1 trials, the compound displayed a favorable safety profile, linear pharmacokinetics with a half-life of ~30 hours, and effective reversal of FXa‑DOAC impact.
VarmX has strengthened its financial position with a €15 million follow-on equity investment from the European Innovation Council (EIC) Accelerator announced on February 25, 2025. This latest funding, approved through a highly competitive evaluation process, will accelerate the clinical development of VMX‑C001.
John Glasspool, VarmX’s CEO, emphasized that IND approval and EIC investment underscore both the scientific potential of VMX‑C001 and the urgent need for universal FXa‑DOAC reversal agents in emergency care.
Read more here: https://varmx.com/news/varmx-receives-ind-approval-for-phase-3-trial-of-vmx-c001-in-urgent-surgery/
