Factor VIII <i>in vitro</i> bioequivalence of denecimig (Mim8) hemostatic effect by thrombin generation assays.

ABSTRACT:

Background

Denecimig (Mim8, Novo Nordisk A/S) is a next-generation bispecific antibody designed to mimic activated factor (F)VIII and restore hemostasis in persons with hemophilia A. The extent to which activated FVIII mimetics, such as denecimig and emicizumab, can correct clotting deficiency remains unclear.

Objectives

To assess the in vitro FVIII bioequivalence of denecimig hemostatic activity using thrombin generation assays (TGAs).

Methods

Thrombin generation was analyzed in severe hemophilia A platelet-poor plasma, spiked with various levels of FVIII or with clinical doses of denecimig (5 μg/mL) or emicizumab (50 μg/mL), using a sequence-identical analog (SIA). TGA used 4 trigger conditions: tissue factor (TF), activated FXI, a combination of TF and activ

SUBMITTER: Lund J 

PROVIDER: S-EPMC12907708 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature