Mim8 prophylaxis treatment shown to be well-tolerated when switching from emicizumab in people with hemophilia A in new phase 3 data presented at the ISTH 2025 Congress

• New FRONTIER5 results show a direct switch to investigational Mim8 (denecimig) prophylaxis treatment from emicizumab, without the need for a washout period, was well-tolerated in adults and adolescents with hemophilia A, with or without inhibitors¹
  
  
• FRONTIER5 Patient-Reported Outcomes assessment found the Mim8 pen-injector easy to use with strong user preference over their emicizumab injection system²

PLAINSBORO, N.J., June 22, 2025 /PRNewswire/ -- Novo Nordisk today presented results from the phase 3b FRONTIER5 trial showing that a direct switch to investigational Mim8 (denecimig) prophylaxis from emicizumab treatment, without a washout period or Mim8 loading dose, was well tolerated in adults and adolescents living with hemophilia A, with or without inhibitors.¹ Additionally, a FRONTIER5 Patient-Reported Outcomes (PROs) assessment found the Mim8 pen-injector easy to use with an overall strong user preference for the pen-injector, in comparison to previous injection systems.² The results were presented at the International Society on Thrombosis and Haemostasis (ISTH) Congress in Washington, D.C.

"Continuous prophylactic coverage is critical to avoiding breakthrough bleeds in people living with hemophilia; with new non-factor therapeutic options, many people could have hesitations about switching treatment options. These data demonstrate that switching to Mim8 from emicizumab can be done without requiring a washout period," said Allison P. Wheeler, MD, Washington Center for Bleeding Disorders, Seattle, WA. "This is critical in ensuring that individuals maintain continuous protection against bleeding events as we seek to help address the ongoing needs of people living with this complex disease."

In the open-label phase 3 FRONTIER5 safety study, 61 adults and adolescents aged 12 years and older with hemophilia A were enrolled.³ No thromboembolic events, hypersensitivity reactions, or treatment-emergent adverse events (TEAEs) leading to discontinuation were observed, and there was no evidence of neutralizing anti-Mim8 antibodies.¹ Additional safety information from FRONTIER5 demonstrate that between Week 0 and Week 26 of treatment, there were 107 TEAEs observed in 43 patients (70.5%), most of which were mild to moderate (88.6%). There were 24 TEAEs that were possibly/probably related to Mim8 reported in 18 patients (29.5%). No thromboembolic events, hypersensitivity reactions, or TEAEs leading to discontinuation were observed.¹

The PROs data from FRONTIER5 indicated overall (97%; n=57/59) patients preferred the Mim8 pen injection, with 97% of those patients reporting a "very strong" or "fairly strong" preference in comparison to their previous emicizumab injection system. Of the participants who completed the Hemophilia Device Handling and Preference Assessment (HDHPA) questionnaire at week 26, 98% (n=58/59) found the Mim8 pen-injector "very easy" or "easy" to use, and 95% (n=56/59) found it "much easier" or "easier" compared with their previous administration method. All participants (100%) were "extremely confident" or "very confident" in using the pen-injector correctly.²

"The FRONTIER5 safety and patient-reported outcomes data support Mim8 as a potential future treatment option for people living with hemophilia A and demonstrate our continued commitment to developing innovative treatment options for the hemophilia community," said Stephanie Seremetis, Chief Medical Officer and CVP for Rare Disease at Novo Nordisk. "These results give valuable insights into hemophilia A management, highlight the feasibility of directly switching to Mim8 from emicizumab, and reveal a strong patient preference for the Mim8 pen-injector device."

Novo Nordisk aims to submit Mim8 for U.S. and EU regulatory review during 2025. Data from the ongoing phase 3 FRONTIER program will be disclosed at upcoming congresses and in publications in 2025 and 2026.

About hemophilia
Hemophilia is a rare inherited bleeding disorder that impairs the body's ability to make blood clots, a process needed to stop bleeding.⁴ It is estimated to affect approximately 1,125,000 people worldwide.⁵ There are different types of hemophilia, which are characterized by the type of clotting factor protein that is defective or missing.⁴ Hemophilia A is caused by a missing or defective clotting Factor VIII (FVIII), and hemophilia B is caused by a missing or defective clotting Factor IX.⁴ Inhibitors are an immune system response to the clotting factors in replacement therapy. Currently, it is estimated that up to 30% of people living with severe hemophilia A have inhibitors that can cause replacement therapies to stop working.⁶

About Mim8
Mim8 is an investigational FVIIIa mimetic bispecific antibody designed with the aim to deliver once-monthly, once-every-two-weeks, or once-weekly prophylaxis for people living with hemophilia A, with or without inhibitors.^7,8 Administered under the skin, Mim8 bridges Factor IXa and Factor X. This action replaces FVIII function, which helps restore the body's thrombin generation capacity, helping blood to clot.^7,9 The use of Mim8 in people living with hemophilia A is investigational and not approved by regulatory authorities or available anywhere in the world.

About the FRONTIER5 trial
FRONTIER5 is a single-arm, open-label, 26-week, phase 3b trial evaluating the safety of switching from previous emicizumab prophylaxis treatment directly to Mim8 prophylaxis treatment using the Mim8 pen-injector in adults and adolescents with hemophilia A, with or without inhibitors.¹

The FRONTIER clinical program investigates Mim8 as a prophylaxis treatment for people with hemophilia A, with or without inhibitors. The phase 3 program includes FRONTIER1, FRONTIER2, FRONTIER3, FRONTIER4 and FRONTIER5.^1,8,10-12

About Novo Nordisk
Novo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. With a U.S. presence spanning 40 years, Novo Nordisk U.S. is headquartered in New Jersey and employs over 10,000 people throughout the country across 12 manufacturing, R&D, and corporate locations in eight states plus Washington DC. For more information, visit novonordisk-us.com, Facebook, Instagram, and X.

Contacts for further information: 

References

1. Oldenberg J, Benson G, Chowdaryet P, et al. FRONTIER5 direct switch study: safety of initiating Mim8 prophylaxis without washout of emicizumab. Oral presentation presented at the Congress of the International Society on Thrombosis and Haemostasis 2025; June 21-25 2025; Walter E. Washington Convention Center, Washington D.C., US. Session code 13686.
2. Mahlangu J, Ahuja S, Cockrell E, et al. FRONTIER5 device handling and patient-reported outcomes. Oral presentation presented at the Congress of the International Society on Thrombosis and Haemostasis 2025; June 21–25 2025; Walter E. Washington Convention Center, Washington D.C., US. Session code 13786.
3. ClinicalTrials.gov. A Research Study Looking at How Safe it is to Switch From Emicizumab to Mim8 in People With Haemophilia A (FRONTIER5). Last accessed May 2025. Available at https://clinicaltrials.gov/study/NCT05878938.
4. MedlinePlus. Hemophilia. Last accessed May 2025. Available at https://medlineplus.gov/genetics/condition/hemophilia.
5. Iorio A, Stonebraker JS, Chambost H, et al. Establishing the Prevalence and Prevalence at Birth of Hemophilia in Males: A Meta-analytic Approach Using National Registries. Ann Intern Med. 2019;171:540-546.
6. Kim JY, You CW. The prevalence and risk factors of inhibitor development of FVIII in previously treated patients with hemophilia A. Blood Res. 2019;54:204-209.
7. Ostergaard H, Lund J, Greisen PJ, et al. A factor VIIIa-mimetic bispecific antibody, Mim8, ameliorates bleeding upon severe vascular challenge in hemophilia A mice. Blood. 2021;138:1258-1268.
8. ClinicalTrials.gov. A Research Study Looking at Long-term Treatment With Mim8 in People With Haemophilia A (FRONTIER4). Last accessed May 2025. Available at https://clinicaltrials.gov/study/NCT05685238.
9. U.S. National Library of Medicine. F8 gene. MedlinePlus Genetics. Last accessed May 2025. Available at https://medlineplus.gov/genetics/gene/f8/.
10. ClinicalTrials.gov. A Research Study Investigating Mim8 in People With Haemophilia A. Last accessed June 2025. Available at https://clinicaltrials.gov/study/NCT04204408.
11. ClinicalTrials.gov. A Research Study Investigating Mim8 in Adults and Adolescents With Haemophilia A With or Without Inhibitors. Last accessed May 2025. Available at https://clinicaltrials.gov/study/NCT05053139.
12. ClinicalTrials.gov. A Research Study Looking at Mim8 in Children With Haemophilia A With or Without Inhibitors. Last accessed May 2025. Available at https://clinicaltrials.gov/study/NCT05306418.

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