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Denecimig (Mim8) prophylaxis over 52 weeks in adolescents and adults with haemophilia A: FRONTIER2 extension study
Journal article   Open access   Peer reviewed

Denecimig (Mim8) prophylaxis over 52 weeks in adolescents and adults with haemophilia A: FRONTIER2 extension study

Victor Jiménez-Yuste, Aby Abraham, Ciprian Tomuleasa, Hazza Alzahrani, Lize van Vulpen, Renchi Yang, Samya Obaji, Sanjay Ahuja, Sophie Susen, Steven R. Lentz, …
Research and practice in thrombosis and haemostasis, Vol.10(6), 106915
08/2026
DOI: 10.1016/j.rpth.2026.106915
url
https://doi.org/10.1016/j.rpth.2026.106915View
Published (Version of record) Open Access

Abstract

Denecimig (Mim8) is a fully human, activated FVIII mimetic bispecific antibody in development for subcutaneous prophylaxis to prevent bleeding in people with haemophilia A (HA). Report efficacy and safety of denecimig over 52 weeks in adolescents and adults from FRONTIER2 (NCT05053139). Males and females (≥12 years) with HA (any severity), with/without inhibitors, were enrolled. In the 26-week main phase, patients previously treated on-demand were randomised to continued on-demand treatment (Arm 1), denecimig once-every-week (QW; Arm 2a) or once-every-month (QM; Arm 2b); patients previously receiving clotting factor concentrate prophylaxis were randomised to denecimig QW (Arm 3) or QM (Arm 4). In the 26-week extension, patients in Arm 1 switched to denecimig QW or QM; other arms followed the same dosing frequency. Annualised bleeding rate (ABR) of treated bleeds was estimated using a negative binomial model. In the main phase, 281 patients were randomised; 272 entered the extension. Estimated mean ABR in the extension for Arm 1 was 0.67 (QW) and 0.79 (QM). Mean ABR over 52 weeks was 0.37, 0.21, 2.02 and 1.65 in Arms 2a, 2b, 3 and 4, respectively. Most baseline target joints resolved. No hypersensitivity reactions, thromboembolic events or clinical evidence of neutralising anti-denecimig antibodies occurred. Injection-site reactions occurred in 1.81% and 1.34% of denecimig QW and QM injections administered, respectively. Patient-reported physical function improved; treatment burden and joint pain reduced. Denecimig maintained low ABRs over 52 weeks, was well tolerated and improved patient-reported outcomes in adolescents and adults with HA with/without inhibitors. [Display omitted]
 Inhibitors Activated FVIII mimetic Haemophilia A Patient-reported outcomes Prophylaxis

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