On Sunday Novo Nordisk, a Denmark-based pharmaceutical company, presented results from the phase 3b FRONTIER5 trial showing that a direct switch to investigational Mim8 (denecimig) prophylaxis from emicizumab treatment, without a washout period or Mim8 loading dose, was well tolerated in adults and adolescents living with haemophilia A, with or without inhibitors.

The company also said that a FRONTIER5 Patient-Reported Outcomes (PROs) assessment found the Mim8 pen-injector easy to use with an overall strong user preference for the pen-injector, in comparison to previous injection systems. The results were presented at the International Society on Thrombosis and Haemostasis (ISTH) Congress in Washington, D.C.

In the open-label phase 3 FRONTIER5 safety study, 61 adults and adolescents aged 12 years and older with haemophilia A were enrolled. No thromboembolic events, hypersensitivity reactions, or treatment-emergent adverse events (TEAEs) leading to discontinuation were observed, and there was no evidence of neutralising anti-Mim8 antibodies. The PROs data from FRONTIER5 indicated overall (97%; n=57/59) patients preferred the Mim8 pen injection, with 97% of those patients reporting a 'very strong' or 'fairly strong' preference in comparison to their previous emicizumab injection system.

Novo Nordisk aims to submit Mim8 for US and EU regulatory review during 2025. Data from the ongoing phase 3 FRONTIER programme will be disclosed at upcoming congresses and in publications in 2025 and 2026.