On May 13, 2024, Novo Nordisk A/S announced positive results from the FRONTIER 2 trial, a phase 3a study evaluating the efficacy and safety of Mim8, a prophylactic treatment for haemophilia A. The trial, which included 254 participants aged 12 and older, demonstrated that both once-weekly and once-monthly subcutaneous injections of Mim8 significantly reduced treated bleeding episodes compared to no prophylaxis and prior coagulation factor prophylaxis treatments. The study met its co-primary endpoints, with once-weekly and once-monthly Mim8 showing reductions of 97% and 99% in treated bleeds, respectively, in participants without prior prophylaxis. Additionally, a majority of participants experienced zero treated bleeds. The intra-patient analysis also revealed substantial reductions in treated bleeds compared to prior prophylaxis. Mim8 was well-tolerated with no reported deaths or...Show More

On May 13, 2024, Novo Nordisk A/S announced positive results from the FRONTIER 2 trial, a phase 3a study evaluating the efficacy and safety of Mim8, a prophylactic treatment for haemophilia A. The trial, which included 254 participants aged 12 and older, demonstrated that both once-weekly and once-monthly subcutaneous injections of Mim8 significantly reduced treated bleeding episodes compared to no prophylaxis and prior coagulation factor prophylaxis treatments. The study met its co-primary endpoints, with once-weekly and once-monthly Mim8 showing reductions of 97% and 99% in treated bleeds, respectively, in participants without prior prophylaxis. Additionally, a majority of participants experienced zero treated bleeds. The intra-patient analysis also revealed substantial reductions in treated bleeds compared to prior prophylaxis. Mim8 was well-tolerated with no reported deaths or thromboembolic events. Novo Nordisk plans to seek regulatory approval for Mim8 by the end of 2024, with further data from the FRONTIER programme to be presented at upcoming congresses and in publications. Haemophilia A is a rare bleeding disorder affecting around 1,125,000 people globally, and Mim8 offers a new prophylactic option for those living with the condition, with or without inhibitors.