VarmX B.V.

VarmX aims to revolutionize the treatment of severe bleeding through a fast, safe, and effective medicine.

VarmX’s lead compound, VMX-C001, is a modified recombinant human blood clotting Factor Xa that enables normal blood clotting, even in the presence of Factor Xa blood clotting inhibitors. VMX-C001 is being developed to facilitate the fast, safe, and effective treatment of severe bleeds in patients that are taking Factor Xa direct oral anticoagulants (DOACs). In addition, it enables patients on this class of blood thinners to undergo emergency surgery reducing the risk of bleeding associated with FXa DOACs.

A clinical development programme is ongoing to fully and robustly evaluate the safety and efficacy of VMX-C001 and support its approval and subsequent access for all patients. However, VarmX also recognises that patients are not always eligible for participation in trials and that access to a medicinal product outside of formal settings may be beneficial where feasible.

The urgent and critical care nature of the clinical settings in which the anticoagulating effects of Factor Xa DOACs must be bypassed (generally in less than 24 hours) do not allow sufficient time for a physician request to be prepared, submitted, reviewed, and approved, and for VMX-C001 to be shipped for administration to an individual patient in time to address their clinical need.

Therefore, VarmX is unable to accept requests for expanded access to VMX-C001.