Phase 3 FRONTIER3 interim analysis data presented at EAHAD 2025 showed that 74.3% of children on once-weekly Mim8 prophylaxis experienced zero treated bleeds
Bagsværd, Denmark, 7 February 2025 – Novo Nordisk today announced interim results from the phase 3 FRONTIER3 trial of 70 children (aged 1-11 years old) with haemophilia A with and without inhibitors. The trial initially assessed once-weekly prophylaxis treatment (regular treatment to prevent prolonged and spontaneous bleeding) with investigational Mim8 before giving participants the option to change to once-monthly dosing after 26 weeks. The data were presented at the 18th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD 2025) in Milan, Italy.
The data showed that Mim8 was well-tolerated and efficacious in children with haemophilia A with and without inhibitors. In part one of the FRONTIER3 study, participants with haemophilia A received once-weekly doses of Mim8 administered under the skin for 26 weeks. In part two, participants had the option to continue with once-weekly dosing or move to once-monthly dosing for the remaining 26 weeks. The interim analysis reports on results at the completion of part one of the study, with some preliminary data shared from part two, which continued following this analysis.
For part one of the study in children on once-weekly prophylaxis, the estimated mean (average) annualised bleeding rate (ABR) for treated bleeds was 0.53. The median (middle or central value in the data set) ABR was zero; 74.3% of participants had zero treated bleeds. All children with haemophilia A with inhibitors (n=14) reported zero treated bleeds. After completing the initial 26 weeks of the study, 45% of participants chose to move to once-monthly Mim8, and the rest (55%) remained on the once-weekly dose.
“Managing haemophilia A in young children can be a complex balancing act of delivering ongoing care, minimising
