Novo Nordisk presented results from its Phase 3b FRONTIER5 trial on Mim8

Novo Nordisk (NVO) presented results from the phase 3b FRONTIER5 trial showing that a direct switch to investigational Mim8 prophylaxis from emicizumab treatment, without a washout period or Mim8 loading dose, was well-tolerated with no safety concerns in adults and adolescents living with haemophilia A, with or without inhibitors. Additionally, a FRONTIER5 Patient-Reported Outcomes assessment found the Mim8 pen-injector easy to use, with an overall strong user preference for the pen-injector compared to the previous emicizumab injection system. The results were presented at the International Society on Thrombosis and Haemostasis, ISTH, Congress in Washington, D.C. In the study, the first Mim8 maintenance dose was administered on the next planned emicizumab dosing day. Patients were given the option of switching to once-monthly, once every two weeks or once-weekly dosing frequencies of Mim8, regardless of their prior dosing frequency. Steady-state Mim8 concentration was achieved by Week 16, and emicizumab elimination was completed by Week 26. Switching to Mim8 led to a sustained increase in thrombin peak levels without an exaggerated thrombin response.