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Monday, Novo Nordisk A/S (NYSE:NVO) 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.
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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 people with no prior prophylaxis treatment, once-weekly and once-monthly Mim8 demonstrated superior reductions of 97% and 99% in treated bleeds, respectively, compared to those who received no prophylaxis treatment.
In addition, 86% of people treated with once-weekly Mim8 and 95% of those treated with once-monthly Mim8 experienced zero treated bleeds, compared to 0% of those treated with no prophylaxis.
In the intra-patient analysis in people with prior coagulation factor prophylaxis, once-weekly and once-monthly Mim8 demonstrated superior reductions of 48% and 43% in treated bleeds, respectively, compared to prior coagulation factor prophylaxis.
Additionally, 66% of people treated with once-weekly Mim8 and 65% of people treated with once-monthly Mim8 experienced zero treated bleeds.
In the trial, Mim8 appeared to have a safe and well-tolerated profile in line with previous trials. No deaths or thromboembolic events were reported in the trial.
Novo Nordisk aims to submit Mim8 for the first regulatory approval towards the end of 2024.
Data from the phase 3 FRONTIER program, including FRONTIER 2 will be disclosed at upcoming congresses and in publications in 2024 and 2025.
Hemophilia is a rare inherited bleeding disorder that impairs the body’s ability to make blood clots, a process needed to stop bleeding. It is estimated to affect approximately 1,125,000 people worldwide, and hemophilia A accounts for 80-85% of all hemophilia cases.
Price Action: NVO shares are up 3.04% at $132.33 at last check Monday.
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Posted In: NVO
