Monday, Novo Nordisk A/S ( 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 ( NVO ) 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.