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Peer-reviewedCC BYResearch and Practice in Thrombosis and Haemostasis

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

  • Victor Jiménez-Yuste1
  • Aby Abraham2
  • Ciprian Tomuleasa3
  • Hazza Alzahrani4
  • Lize van Vulpen5
  • Renchi Yang6
  • Samya Obaji7
  • Sanjay Ahuja8
  • Sophie Susen9
  • Steven R. Lentz10
  • Amalie Roar Høgh11
  • Ilgiz Rakhmatullin11
1 more authors
  • Cédric Hermans12
12 affiliations
  1. 1Hospital Universitario La Paz (IdiPAZ), Universidad Autónoma de Madrid, Madrid, Spain
  2. 2Department of Clinical Haematology, Christian Medical College, Vellore, Tamil Nadu, India
  3. 3Hemostasis Lab, Department of Personalized Medicine and Rare Diseases, Medfuture Institute for Biomedical Research/Department of Hematology, Iuliu Hațieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania
  4. 4Department of Hematology, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia
  5. 5Center for Benign Haematology, Thrombosis & Haemostasis, Van Creveldkliniek, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
  6. 6Thrombosis and Hemostasis Center, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China
  7. 7Cardiff Haemophilia Centre, University Hospital of Wales, Cardiff, UK
  8. 8Rainbow Babies and Children’s Hospital, Cleveland, Ohio, USA
  9. 9Hemostasis and Transfusion Department, University of Lille, Lille University Hospital, Lille, France
  10. 10Department of Internal Medicine, University of Iowa, Iowa City, Iowa, USA
  11. 11Novo Nordisk A/S, Søborg, Denmark
  12. 12Haemostasis and Thrombosis Unit, Division of Hematology, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (UCLouvain), Brussels, Belgium; European Reference Network on Rare Hematological Diseases (ERN EuroBloodNet)
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Abstract

Background: Denecimig (Mim8) is a fully human, activated factor VIII (FVIII) mimetic bispecific antibody in development for subcutaneous prophylaxis to prevent bleeding in persons with hemophilia A (HA). Objectives: This study aimed to report the efficacy and safety of denecimig over 52 weeks in adolescents and adults from FRONTIER2 (NCT05053139). Methods: Males and females (aged ≥12 years) with HA (any severity), with or without inhibitors, were enrolled. In the 26-week main phase, patients previously treated on-demand were randomized to continue on-demand treatment (arm 1) or receive denecimig injections once every week (QW; arm 2a) or once every month (QM; arm 2b); patients previously receiving clotting factor concentrate prophylaxis were randomized to receive 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. Annualized bleeding rate (ABR) of treated bleeds was estimated using a negative binomial model. Results: In the main phase, 281 patients were randomized; 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 neutralizing anti-denecimig antibodies occurred. Injection-site reactions occurred in 1.81% and 1.34% of patients administered denecimig QW and QM injections, respectively. Patient-reported physical function improved; treatment burden and joint pain was reduced. Conclusions: Denecimig maintained low ABRs over 52 weeks, was well tolerated, and improved patient-reported outcomes in adolescents and adults with HA with or without inhibitors.

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Cite

BibTeXRIS
BibTeX
@article{jimenezyuste2026denecimig,
  title = {{Denecimig (Mim8) prophylaxis over 52 weeks in adolescents and adults with hemophilia A: FRONTIER2 extension study}},
  author = {Victor Jiménez-Yuste and Aby Abraham and Ciprian Tomuleasa and Hazza Alzahrani and Lize van Vulpen and Renchi Yang and Samya Obaji and Sanjay Ahuja and Sophie Susen and Steven R. Lentz and Amalie Roar Høgh and Ilgiz Rakhmatullin and Cédric Hermans},
  journal = {Research and Practice in Thrombosis and Haemostasis},
  year = {2026},
  month = aug,
  doi = {10.1016/j.rpth.2026.106915},
  url = {https://doi.org/10.1016/j.rpth.2026.106915},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - Denecimig (Mim8) prophylaxis over 52 weeks in adolescents and adults with hemophilia A: FRONTIER2 extension study
AU  - Victor Jiménez-Yuste
AU  - Aby Abraham
AU  - Ciprian Tomuleasa
AU  - Hazza Alzahrani
AU  - Lize van Vulpen
AU  - Renchi Yang
AU  - Samya Obaji
AU  - Sanjay Ahuja
AU  - Sophie Susen
AU  - Steven R. Lentz
AU  - Amalie Roar Høgh
AU  - Ilgiz Rakhmatullin
AU  - Cédric Hermans
PY  - 2026
DA  - 2026/08/01
JO  - Research and Practice in Thrombosis and Haemostasis
DO  - 10.1016/j.rpth.2026.106915
UR  - https://doi.org/10.1016/j.rpth.2026.106915
AB  - Background: Denecimig (Mim8) is a fully human, activated factor VIII (FVIII) mimetic bispecific antibody in development for subcutaneous prophylaxis to prevent bleeding in persons with hemophilia A (HA). Objectives: This study aimed to report the efficacy and safety of denecimig over 52 weeks in adolescents and adults from FRONTIER2 (NCT05053139). Methods: Males and females (aged ≥12 years) with HA (any severity), with or without inhibitors, were enrolled. In the 26-week main phase, patients previously treated on-demand were randomized to continue on-demand treatment (arm 1) or receive denecimig injections once every week (QW; arm 2a) or once every month (QM; arm 2b); patients previously receiving clotting factor concentrate prophylaxis were randomized to receive 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. Annualized bleeding rate (ABR) of treated bleeds was estimated using a negative binomial model. Results: In the main phase, 281 patients were randomized; 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 neutralizing anti-denecimig antibodies occurred. Injection-site reactions occurred in 1.81% and 1.34% of patients administered denecimig QW and QM injections, respectively. Patient-reported physical function improved; treatment burden and joint pain was reduced. Conclusions: Denecimig maintained low ABRs over 52 weeks, was well tolerated, and improved patient-reported outcomes in adolescents and adults with HA with or without inhibitors.
SN  - 2475-0379
ER  -