News Details - Novo Nordisk
May 13, 2024 · Novo Nordisk A/S: Once-weekly and once-monthly Mim8 demonstrate superior reduction of treated bleeding episodes compared to on-demand and prior prophylaxis treatment in people with haemophilia A in the Frontier 2 trial.
Mim8 - a Next-Generation FVIII Mimetic Bi-Specific Antibody
Nov 13, 2019 · Mim8 is a highly potent molecule bridging factor IXa (FIXa) and factor X (FX) in development for subcutaneous treatment of people with HA and HAwI. Development of Mim8 utilized the Duobody ® platform to initially screen for compatible anti-FIXa and anti-FX antibodies followed by several iterations of systematic mutational optimization.
Mim8 Clinical Development Program: An Overview of the Frontier …
Nov 15, 2022 · Preclinical data demonstrate that Mim8 is highly potent with an efficacious hemostatic effect. The FRONTIER program aims to expedite Mim8 development, recruiting participants from >30 countries including women, previously untreated patients (PUPs), and patients with mild/moderate disease severity.
Mim8, a novel factor VIIIa mimetic bispecific antibody, shows
Aug 23, 2023 · Background: Mim8 (denecimig) is a novel activated coagulation factor VIII-mimetic bispecific antibody that assembles with activated coagulation FIX and FX on the platelet membrane surface. Objectives: The FRONTIER1 (NCT04204408, NN7769-4513) single ascending dose and the 4882 pharmacokinetic (PK) studies (NCT05127473, NN7769-4882) examined the ...
Mim8, a novel factor VIIIa mimetic bispecific antibody, shows …
Aug 1, 2023 · Mim8 (denecimig) is a novel FVIIIa-mimetic biAb with an improved potency that binds to activated coagulation FIX (FIXa) and FX, thereby enhancing the catalytic activity of FIXa for the conversion of FX on the surface of activated platelets [6, 9].
Novo Nordisk A/S: Once-weekly and once-monthly Mim8 …
May 13, 2024 · Contingent on regulatory interactions, Novo Nordisk aims to submit Mim8 for the first regulatory approval towards the end of 2024. Data from the phase 3 FRONTIER programme, including FRONTIER...
Novo Nordisk A/S: Mim8 demonstrated superior reductions in
Jun 23, 2024 · Mim8 demonstrated a superior reduction in the estimated mean annualised bleeding rate (ABR) of treated bleeds by 97.1% with once-weekly and 98.7% with once-monthly Mim8.
Novo Nordisk A/S: Mim8 demonstrated superior reductions in …
Jun 23, 2024 · Mim8 demonstrated a superior reduction in the estimated mean annualised bleeding rate (ABR) of treated bleeds by 97.1% with once-weekly and 98.7% with once-monthly Mim8.
Novo Nordisk A/S: Once-weekly and once-monthly Mim8 …
May 13, 2024 · Contingent on regulatory interactions, Novo Nordisk aims to submit Mim8 for the first regulatory approval towards the end of 2024. Data from the phase 3 FRONTIER programme, including FRONTIER...
• Mim8 is a novel drug under development for patients with hemophilia A. • We report the safety, tolerability, pharmacokinetics, and pharmacodynamics of Mim8. • Mim8 was well tolerated, and there were no severe adverse effects from treatment.