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On Friday, Novo Nordisk A/S (NYSE: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 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. (NASDAQ: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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