Novo Nordisk has announced they will launch a new study to assess the safety and efficacy of Mim8 therapy in individuals aged 1 year and older with hemophilia A. The interventional study is a phase 3, nonrandomized, parallel-assignment trial that will enroll up to 425 participants with hemophilia A with or without inhibitors.
Mim8 is a novel anti-factor (F) IXa/anti-FX bispecific antibody. It is designed to prevent bleeding episodes by replacing the function of clotting FVIII, which is missing or reduced in this patient population. It is administered subcutaneously in the abdomen using an enhanced cartridge or pen injector.
The participants in this study will have been enrolled in previous Mim8 studies, and the frequency and number of Mim8 injections each participant receives will depend on the prior Mim8 study they were in. The prior studies are NN7769-4513, NN7769-4514, and NN7769-4516.
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In part 1 of the new study, individuals from the first prior study will receive Mim8 prophylaxis via an enhanced cartridge every 2 weeks for 26 weeks. In part 2, these patients will receive Mim8 prophylaxis every week or once monthly via an enhanced cartridge or pen injector. Patients from the other 2 prior studies will receive Mim8 prophylaxis once weekly or once monthly for 26 weeks, and in part 2, they will receive it weekly, every 2 weeks, or monthly via a pen injector.
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The primary outcome measure will be the number of treatment-emergent adverse events. Secondary outcome measures include injection site reactions, anti-Mim8 antibody development, number and types of bleeding episodes, Mim8 plasma concentrations, and hemophilia device handling.
The study is expected to launch on February 3, 2023, and the estimated completion date is April 28, 2028.
Reference
A research study looking at long-term treatment with Mim8 in people with haemophilia A (FRONTIER 4) (FRONTIER4). ClinicalTrials.gov. January 17, 2023. Updated January 20, 2023. Accessed January 30, 2023.
