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Novo Nordisk's Mim8 have shown significant superiority in reducing treated bleeding episodes compared to SoC in hemophilia A patients | iPharmaCenter

Once-weekly and once-monthly Mim8 have shown significant superiority in reducing treated bleeding episodes compared to on-demand and previous prophylaxis treatments in individuals with hemophilia A, as demonstrated in the Frontier 2 trial.

Novo Nordisk recently announced the primary results from the FRONTIER 2 trial, a crucial phase 3a, 26-week open-label, randomized, controlled, multi-arm study involving 254 participants. This trial assessed the efficacy and safety of once-weekly and once-monthly subcutaneous Mim8 versus no prophylaxis and previous coagulation factor prophylaxis treatment in individuals aged 12 and older with hemophilia A, with or without inhibitors.

The trial met its co-primary endpoints by showing a statistically significant and superior reduction in treated bleeding episodes with both once-weekly and once-monthly Mim8 compared to no prophylaxis and prior coagulation factor prophylaxis treatments.

Among participants with no prior prophylaxis treatment, once-weekly and once-monthly Mim8 achieved superior reductions of 97% and 99% in treated bleeds, respectively, compared to those without prophylaxis. Additionally, 86% of those treated with once-weekly Mim8 and 95% of those treated with once-monthly Mim8 experienced zero treated bleeds, compared to 0% in the no prophylaxis group.

In the intra-patient analysis for participants with previous coagulation factor prophylaxis, once-weekly and once-monthly Mim8 showed superior reductions of 48% and 43% in treated bleeds, respectively, compared to prior prophylaxis (during the 26-52 weeks run-in period before starting Mim8).

Moreover, 66% of individuals treated with once-weekly Mim8 and 65% of those treated with once-monthly Mim8 had zero treated bleeds.

Mim8 exhibited a safe and well-tolerated profile consistent with previous trials, with no deaths or thromboembolic events reported.

Pending regulatory discussions, Novo Nordisk plans to seek the first regulatory approval for Mim8 by the end of 2024. Findings from the phase 3 FRONTIER program, including FRONTIER 2, will be presented at upcoming conferences and published in 2024 and 2025.

Hemophilia is a rare genetic bleeding disorder that affects the body's ability to form blood clots, necessary to stop bleeding.

It is estimated to affect approximately 1,125,000 people globally, with hemophilia A accounting for 80-85% of cases.

As a rare X-linked recessive disorder, hemophilia often presents differently in males compared to females, with about 88% of diagnosed individuals being male. Hemophilia types are defined by the specific clotting factor protein that is missing or defective. Hemophilia A results from a deficiency or defect in clotting Factor VIII (FVIII). Some individuals with hemophilia may develop inhibitors, an immune response to replacement therapy clotting factors that render the treatment ineffective. Currently, it is estimated that up to 30% of people with hemophilia A have inhibitors.

Mim8 is a next-generation FVIIIa mimetic bispecific antibody designed for sustained hemostasis with once-weekly or once-monthly prophylaxis for individuals with hemophilia A, with and without inhibitors. Administered subcutaneously, Mim8 connects Factor IXa and Factor X upon activation, replacing the missing FVIII, thereby restoring the body's ability to generate thrombin and promote blood clotting effectively.


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