Danish pharmaceutical company Novo Nordisk has reported headline results from FRONTIER II, a Phase IIIa trial of subcutaneous Mim8 in treating haemophilia A.
The randomised, open-label trial lasted 26 weeks and enrolled 254 participants aged 12 years and older.
It compared the safety and efficacy of once-weekly and once-monthly subcutaneous doses of Mim8 against no prophylaxis and prior previous coagulation factor prophylaxis treatment.
The trial met its co-primary endpoints, demonstrating a statistically significant decline in treated bleeding episodes with both tested doses of Mim8 compared with no prophylaxis and prior coagulation factor prophylaxis therapy.
Reductions of 97% and 99% were observed in patients without prior prophylaxis treatment when treated with once-weekly and once-monthly Mim8s, respectively.
In addition, 86% of subjects treated weekly and 95% of those treated monthly experienced no treated bleeds, in contrast to 0% of those without prophylaxis.
In patients who had previously received coagulation factor prophylaxis, once-weekly and once-monthly Mim8 doses showed reductions of 48% and 43% in treated bleeds, respectively.
Mim8 was reported to be safe and well-tolerated, with no deaths or thromboembolic events occurring during the trial.
Novo Nordisk plans to seek regulatory approval for Mim8 by the end of this year, based on interactions with regulatory bodies.
Novo Nordisk Development executive vice-president Martin Holst Lange said: “We are very pleased with the positive results from the FRONTIER II clinical trial.
“These data demonstrate the ability of Mim8 to prevent bleeding episodes effectively and safely in people with haemophilia A, regardless of their dosing frequency.
“Given the differing needs of people living with haemophilia A, a convenient once-weekly or once-monthly dosing provides optionality and flexibility for people living with haemophilia A with or without inhibitors.”
Earlier this month, Novo Nordisk dosed the first subject in a Phase I clinical trial of NNC6022-0001 (formerly known as VENT-01) as a potential treatment for various conditions.
