Research and practice in thrombosis and haemostasis
Denecimig (Mim8) prophylaxis in children with hemophilia A with or without factor VIII inhibitors
By Kenet G, Berrueco R, Fijnvandraat K and 8 others.
Abstract
Background
Denecimig (Mim8) is a next-generation activated factor (F)VIII mimetic bispecific antibody developed for subcutaneous prophylaxis in patients with hemophilia A (HA).
Objectives
This study evaluated 52-week outcomes with denecimig in children from the phase 3 FRONTIER3 study (NCT05306418).
Methods
Children aged 1 to 11 years with HA with or without FVIII inhibitors, received subcutaneous denecimig once every week (QW) for 26 weeks (Part 1). In Part 2, caregivers chose to continue QW or switch to once-every-month (QM) dosing for 26 weeks. Primary end point was the number of treatment-emergent adverse events. Assessed secondary outcomes included the number of treated bleeds and subtypes, injection-site reactions, antidenecimig antibodies, and caregiver-reported outcomes.