Novo Nordisk shares positive results for Mim8 in late-stage haemophilia A trial

26 Jun 2024
pmlive.com
Clinical ResultPhase 3Phase 2
Novo Nordisk shares positive results for Mim8 in late-stage haemophilia A trial
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Source: PMLiVE
Novo Nordisk has shared positive results from a late-stage study of its haemophilia A therapy, Mim8, in adults and adolescents aged 12 years and older.
The rare inherited bleeding disorder is caused by a missing or defective clotting factor VIII and accounts for up to 85% of the 1,125,000 global haemophilia cases.
The phase 3 FRONTIER 2 trial has been evaluating the safety and efficacy of a once-weekly and once-monthly dose of Novo’s subcutaneously administered therapy to prevent prolonged and spontaneous bleeding in patients with or without inhibitors.
It is estimated that up to 30% of haemophilia A patients have inhibitors, an immune system response to the clotting factors in replacement therapy that cause treatment to stop working.
According to the results presented at this year’s International Society of Thrombosis and Haemostasis Annual Congress, 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 in the trial population with no prior prophylaxis treatment.
Once-weekly and once-monthly Mim8 prophylaxis also demonstrated a superior reduction in treated bleeds compared to no prior prophylaxis treatment, and zero bleeds were observed in 85.7% of patients treated with once-weekly Mim8 and in 95% of those receiving a once-monthly dose of the therapy.
In the study cohort 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, and also showed a superior reduction in treated bleeds compared to prior coagulation factor prophylaxis. Zero bleeds were observed in 66.3% of patients in the once-weekly Mim8 treatment arm and 65.3% of those receiving once-monthly Mim8.
Novo said it aims to submit Mim8 for the first regulatory approval towards the end of this year.
Martin Holst Lange, executive vice president of development at Novo, described the data as “very encouraging”.
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