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
Year: 2025
Type: article
Abstract: 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).
Authors: 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, Kaan Kavakli
Institutions: Novo Nordisk (United States), Queen Giovanna Hospital, University of Bern, University Hospital of Bern, Instytut Hematologii i Transfuzjologi, Hospital Universitario La Paz, Universidad Autónoma de Madrid, Novo Nordisk Pharma, SA (Spain), University of Southern California, Children's Hospital Los Angeles, Nagoya University Hospital, The Royal Free Hospital, Ege University
Language: English
Subfield: Hematology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,250
OpenAlex ID: W4417207129