Zinger Key Points
- In a phase 3 trial, 74.3% of children on once-weekly Mim8 had zero treated bleeds.
- After 26 weeks, 45% of participants switched to once-monthly dosing.
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On Friday, Novo Nordisk A/S NVO announced interim results from the phase 3 FRONTIER3 trial of 70 children (aged 1-11 years old) with hemophilia A with and without inhibitors.
The trial initially assessed once-weekly prophylaxis treatment (regular treatment to prevent prolonged and spontaneous bleeding) with investigational Mim8 before giving participants the option to change to once-monthly dosing after 26 weeks.
In part one of the FRONTIER3 study, participants received once-weekly doses of Mim8 for 26 weeks.
In part two, participants could continue with once-weekly dosing or move to once-monthly dosing for the remaining 26 weeks.
- The interim analysis reports results after part one of the study, with some preliminary data shared from part two, which continued following this analysis.
- For part one of the study in children on once-weekly prophylaxis, the estimated mean (average) annualized bleeding rate (ABR) for treated bleeds was 0.53.
The median ABR was zero; 74.3% of participants had zero treated bleeds.
All children with hemophilia A with inhibitors (n=14) reported zero treated bleeds. After completing the initial 26 weeks of the study, 45% of participants moved to once-monthly Mim8, and the rest (55%) remained on the once-weekly dose.
The data showed that Mim8 was well-tolerated and efficacious.
Novo Nordisk expects Mim8 regulatory submission during 2025. Data from the ongoing phase 3 FRONTIER program will be disclosed at upcoming congresses and in publications in 2025 and 2026.
In May 2024, Novo Nordisk released headline results from the FRONTIER 2 Phase 3a trial of once-weekly and once-monthly subcutaneous Mim8 versus no prophylaxis and versus prior coagulation factor prophylaxis treatment in hemophilia A patients 12 years or older with or without inhibitors.
The trial achieved its co-primary endpoints by demonstrating a statistically significant and superior reduction of treated bleeding episodes with both once-weekly and once-monthly Mim8 versus no prophylaxis treatment and prior coagulation factor prophylaxis treatment.
In June 2024, Novo Nordisk acquired the Hemophilia A program and rights to 2seventy Bio Inc. TSVT in vivo gene editing technology outside of oncology and gene editing for autologous or allogeneic cell therapies of immune cells for autoimmune disease.
Price Action: NVO stock is down 2.33% at $89.20 during the premarket session on last check Friday.
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