A Research Study Investigating Mim8 in People With Haemophilia A

Summary

This study is investigating how Mim8 works in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medication that will be used for prevention of bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Mim8 will be injected with a thin needle in the skin of the stomach, using a pen-injector. The study will last for up to 44 months. It consists of a main phase (part 1 and part 2) and an extension phase. In part 1, participants will be injected only once with either Mim8 or a "dummy" medicine (placebo) - which one will be decided by chance. In part 2 and the extension phase participants will get an Mim8 injection weekly or monthly.

Timeline

Start

2020-01-10

Primary completion

2023-10-06

Completion

2023-10-06

Publications

• Chowdary P, Lentz SR, Gil L, Lopez-Jaime FJ, Windyga J, Ong Clausen WH, Laursen PN, Mahlangu J. FRONTIER1 multiple ascending dose extension: a safety, tolerability, pharmacokinetics, and pharmacodynamics study of Mim8 in people with hemophilia A. Res Pract Thromb Haemost. 2025 Oct 8;9(7):103207. doi: 10.1016/j.rpth.2025.103207. eCollection 2025 Oct.

Drugs

Indications