Novo Nordisk says Mim8 demonstrated superior reductions in ABR in trial

Novo Nordisk announced results from the phase 3 FRONTIER2 trial of 254 adults and adolescents aged 12 years and over with haemophilia A, with and without inhibitors. The trial assessed both once-weekly and once-monthly prophylactic treatment with the investigational treatment Mim8. The data were presented at the International Society of Thrombosis and Haemostasis Annual Congress in Bangkok, Thailand. In the trial population with no prior prophylaxis treatment: Mim8 demonstrated a superior reduction in the estimated mean annualised bleeding rate, or ABR, of treated bleeds by 97.1% with once-weekly and 98.7% with once-monthly Mim8; Once-weekly and once-monthly Mim8 prophylaxis demonstrated a superior reduction in treated bleeds, as evidenced by an estimated mean ABR of 0.45 and 0.20 bleeds per patient-year, respectively, compared to an estimated mean ABR of 15.75 for those who received no prior prophylaxis treatment; Zero bleeds were observed in 85.7% of people treated with once-weekly Mim8 and 95.0% of those treated with once-monthly Mim8. “The FRONTIER2 efficacy and safety data is very encouraging,” said Martin Holst Lange, Executive Vice President of Development at Novo Nordisk. “With Mim8, we have the potential of offering a substantial proportion of patients the prospect of zero bleeds and convenient dosing flexibility to fit their lifestyles and needs. We look forward to discussing these data with regulatory authorities.” Contingent on regulatory interactions, Novo Nordisk aims to submit Mim8 for the first regulatory approval towards the end of 2024. Data from the ongoing phase 3 FRONTIER programme will continue to be disclosed at upcoming congresses and in publications in 2024 and 2025.