A Research Study Investigating Mim8 in Adults and Adolescents With Haemophilia A With or Without Inhibitors

Summary

This study is investigating how Mim8 works compared to other medicines in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used for prevention of bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). When and how often participants will receive Mim8 is dependent on their previous treatment - but is otherwise decided by chance. Mim8 will be injected into a skinfold on the stomach with a thin needle either once a week or once a month. The study will last 54-124 weeks (12-29 months) depending on how long participants will be followed in run-in before they start treatment and if they continue in the follow period or transfer to an open label extension study. Participants will have 12-17 clinic visits.

Timeline

Start

2021-12-02

Primary completion

2024-03-11

Completion

2024-12-17

Outcome

Met primary endpoint

paper Mim8 prophylaxis was superior to on-demand treatment and clotting factor concentrate prophylaxis regarding the annualized rate of treated bleeding events. PMID 42054679 ↗

Publications

• Mancuso ME, Chan AKC, Shanmukhaiah C, Lyu CJ, Zdziarska J, Mahlangu J, van Vulpen LFD, Chowdary P, Yang R, Lentz SR, Matsushita T, Clausen WHO, Rakhmatullin I, Oldenburg J; FRONTIER2 Investigators. Mim8 Bispecific Antibody Prophylaxis in Hemophilia A with or without Inhibitors. N Engl J Med. 2026 Apr 30;394(17):1696-1709. doi: 10.1056/NEJMoa2517384.
• Ong Clausen WH, Latendorf T, Stehr R, Ezban M, Lund J. Comparative ex vivo analysis of Mim8 in thrombin generation assays triggered by activated factor XI or tissue factor. Res Pract Thromb Haemost. 2025 Oct 10;9(7):103209. doi: 10.1016/j.rpth.2025.103209. eCollection 2025 Oct.

Drugs

Indications