Denecimig (Mim8) prophylaxis once every 2 weeks for hemophilia A with or without inhibitors: 26-week results from FRONTIER4.
Tadashi Matsushita, Atanas Banchev, Julien Bovet et al.
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In 30 seconds
This open-label extension study evaluated every-2-week (Q2W) denecimig prophylaxis in patients aged ≥12 years with hemophilia A, with or without inhibitors, who had previously received denecimig in a phase 2 study and its extension. In the 26-week interim analysis, 37 patients received Q2W dosing. The estimated mean annualized bleeding rate was 0.38 bleeds per patient year, and 83.8% of patients had no treated bleeds. Most treatment-emergent adverse events were mild or moderate; none led to permanent discontinuation or were fatal.
Key findings
- The estimated mean annualized bleeding rate was 0.38 bleeds per patient year; 83.8% of patients experienced zero treated bleeds.
- Sixty treatment-emergent adverse events occurred in 20 patients; 98.3% were mild or moderate, and none were fatal or led to permanent discontinuation.
- Two patients reported 14 injection site reactions, and denecimig plasma concentrations remained stable through week 26.
Why it matters
The findings provide 26-week evidence on bleeding outcomes and tolerability with a Q2W prophylaxis schedule in previously treated patients with hemophilia A. The low observed treated-bleed burden and absence of fatal events or permanent discontinuations are relevant to evaluating this dosing approach, while the open-label extension design and selected study population limit broader conclusions.
What to keep in mind
This was an interim analysis of an open-label extension involving patients previously treated with denecimig; the reported Q2W follow-up was 26 weeks.