HTRS2025.P2.77 Once every two weeks administration of Mim8 prophylaxis for patients with hemophilia A with or without inhibitors: Interim safety and efficacy analysis of the FRONTIER4 open-label extension study
Makaleler > Tam Makale · 2025
Yazarlar: Vlady Ostrow, Atanas Banchev, Johanna A. Kremer Hovinga, Jerzy Windyga, Victor Jiménez-Yuste, Julien Bovet, Llenalia María García Fernández, Guy Young, Tadashi Matsushita, Pratima Chowdary, Ramazan Kaan KAVAKLI
Research and Practice in Thrombosis and Haemostasis, Uluslararası, Wos, 2025, cilt 9, ss 103096-103096
DOI: 10.1016/j.rpth.2025.103096
Özet
Background: Mim8 (denecimig) is a next-generation, activated factor VIII mimetic, fully human bispecific IgG4 antibody in development as a subcutaneous prophylaxis for patients with hemophilia A (HA) with or without factor VIII inhibitors. In the phase 2, open label, multiple ascending dose part of the FRONTIER1 study (NCT04204408), Mim8 was well tolerated with no safety concerns and few treated bleeding episodes beyond the lowest dose cohort. Efficacy for reducing annualized bleeding rate (ABR) and safety of weekly (QW) or monthly (QM) prophylaxis were established in the phase 3 FRONTIER2 study (NCT05053139).