Novo Nordisk A/S (NVO) announced that data from the phase 3 FRONTIER2 trial demonstrated the superiority of Mim8 prophylaxis over both on-demand treatment and prior clotting factor prophylaxis in people living with hemophilia A, regardless of their inhibitor status.Encouragingly, in certain studied subgroups, up to 95% of individuals treated with Mim8 experienced no instances of bleeding.
The company announced the results from the phase 3 FRONTIER2 trial of 254 adults and adolescents aged 12 years and over with haemophilia A, with and without inhibitors.
In the trial population with no prior prophylaxis treatment: Mim8 demonstrated a superior reduction in the estimated mean annualised bleeding rate (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.
In the trial population with prior coagulation factor prophylaxis: Mim8 demonstrated a superior reduction in the estimated mean ABR by 48% for once-weekly and 42.6% for once-monthly treatment; Once-weekly and once-monthly Mim8 demonstrated a superior reduction in treated bleeds compared to prior coagulation factor prophylaxis; Estimated mean ABRs for treated bleeds were 2.51 bleeds per patient-year for once-weekly Mim8 (versus 4.83 on prior clotting factor prophylaxis) and 1.78 bleeds per patient-year for once-monthly Mim8 (versus 3.10 on prior clotting factor prophylaxis);Zero bleeds were observed in 66.3% of participants treated with once-weekly Mim8 and 65.3% treated with once-monthly Mim8.
Mim8 is a next-generation Factor VIIIa (FVIIIa) mimetic bispecific antibody designed with the potential to deliver sustained haemostasis. It is currently in development for once-weekly or once-monthly prophylaxis treatment for people living with haemophilia A, with and without inhibitors.
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