Novo Nordisk Reports Success of Phase III FRONTIER3 Trial for FIX/FX Bispecific Antibody Mim8 in Pediatric Hemophilia A

▎Armstrong

On February 7, 2025, Novo Nordisk announced the latest data from the Phase III clinical trial FRONTIER3 of FIX/FX bispecific antibody Min8 for the treatment of pediatric Hemophilia A. The study is divided into two parts: the first part involves 26 weeks of once-weekly treatment, and in the second part, the remaining 26 weeks are switched to once-monthly or maintained as once-weekly treatment. For the first part, the mean annualized bleeding rate (ABR) was 0.53, and the median ABR was 0. 45% of patients subsequently switched to once-monthly treatment, while 55% of patients remained on once-weekly treatment.

Novo Nordisk plans to submit the marketing application for Mim8 within this year.

Mim8 is a FIX/FX bispecific antibody, which has shown 15 times higher in vitro activity compared to Roche's Emicizumab. PK/PD data supports dosing from once a week to once a month. Previously,In May 2024, Novo Nordisk announced the success of the phase III clinical trial FRONTIER 2 for Mim8 in treating hemophilia.

Summary

Roche's Hemlibra is currently the only marketed FIX/FX bispecific antibody, with sales reaching $5.36 billion in 2024, making it the best-selling hemophilia drug on the market. Chugai Pharmaceutical, a subsidiary of Roche, is also developing an iterative FIX/FX bispecific antibody, NXT007, which has a longer half-life and is expected to achieve a longer dosing interval (once a month for maintenance therapy).