Novo Nordisk announced the headline results from the FRONTIER 2 trial, a pivotal phase 3a study involving 254 participants over 26 weeks. This open-label, randomized, controlled, multi-arm trial assessed the efficacy and safety of once-weekly and once-monthly subcutaneous Mim8 compared to no prophylaxis and prior coagulation factor prophylaxis in individuals aged 12 and older with hemophilia A, with or without inhibitors.
The trial met its co-primary endpoints, showing that both once-weekly and once-monthly Mim8 significantly reduced treated bleeding episodes compared to no prophylaxis and prior coagulation factor prophylaxis.
In patients without prior prophylaxis, once-weekly Mim8 reduced treated bleeds by 97%, and once-monthly Mim8 by 99%, compared to no prophylaxis. Additionally, 86% of those on once-weekly Mim8 and 95% on once-monthly Mim8 experienced zero treated bleeds, versus 0% with no prophylaxis.
For patients previously on coagulation factor prophylaxis, once-weekly Mim8 reduced treated bleeds by 48%, and once-monthly Mim8 by 43%, compared to their prior treatment. Furthermore, 66% of patients on once-weekly Mim8 and 65% on once-monthly Mim8 had zero treated bleeds.
Mim8 was well-tolerated with no deaths or thromboembolic events reported.
“These positive results show Mim8’s potential to effectively and safely prevent bleeding episodes in people with hemophilia A, regardless of dosing frequency,” said Martin Holst Lange, executive VP for Development at Novo Nordisk. He highlighted the flexibility and convenience offered by once-weekly or once-monthly dosing.
Novo Nordisk plans to seek regulatory approval for Mim8 by the end of 2024, with data from the FRONTIER program, including FRONTIER 2, to be presented at upcoming congresses and publications in 2024 and 2025.
