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 - Seite 2

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 2 will be disclosed at upcoming congresses and in publications in 2024 and 2025.

About Haemophilia
Haemophilia 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 haemophilia A is estimated to account for 80-85% of all haemophilia cases. Due to the nature of haemophilia being a rare x-linked recessive disorder, it often presents differently in males compared to females, with ~ 88% of people diagnosed with haemophilia worldwide being male. There are different types of haemophilia, which are characterised by the type of clotting factor protein that is defective or missing. Haemophilia A is caused by a missing or defective clotting Factor VIII (FVIII). Some people with haemophilia may also develop inhibitors, which are an immune system response to the clotting factors in replacement therapy that cause treatment to stop working. Currently, it is estimated that up to 30% of people living with haemophilia A have inhibitors.

About Mim8
Mim8 is a next-generation FVIIIa mimetic bispecific antibody delivering sustained haemostasis for once-weekly or once-monthly prophylaxis for people living with haemophilia A, with and without inhibitors. Administered subcutaneously, Mim8 bridges Factor IXa/X (FIXa/FX) together upon activation, thereby replacing missing FVIII, which effectively restores the body’s thrombin generation capacity, helping blood to clot.

About the FRONTIER Programme
The FRONTIER clinical development programme investigates Mim8 as a preventative treatment for people with haemophilia A, with or without inhibitors. The phase 3 programme includes:

FRONTIER 2 – a 52-week efficacy and safety phase 3 trial, with a 26-52-week run-in period comparing once-weekly and once-monthly Mim8 versus no prophylaxis, and versus prior coagulation factor prophylaxis treatment prior to enrolment in people aged 12 years and over with haemophilia A, with or without inhibitors. Following the completion of the 26-week main phase of the trial, a 26-week extension phase is ongoing.

FRONTIER 3 – a 52-week safety and efficacy phase 3 trial in paediatric patients with haemophilia A, with or without inhibitors (1-11 years). People will receive once-weekly Mim8 during the first 26 weeks and may subsequently choose to receive once-monthly Mim8.