Key Takeaways
- Well-Tolerated Switch to Mim8: Phase IIIb FRONTIER5 trial shows patients with hemophilia A can safely switch from Hemlibra (emicizumab) to Mim8 without a washout period or loading dose.
- Strong Patient Preference: Ninety-seven percent of participants preferred the Mim8 pen-injector over Hemlibra, citing ease of use and confidence in administration.
- Promising Treatment Option: Mim8 demonstrated a favorable safety profile with potential as an innovative prophylactic therapy for hemophilia A.
Results from the Phase IIIb FRONTIER5 trial show that Novo Nordisk’s Mim8 (denecimig) was well tolerated when administered without a washout period or loading dose in patients with hemophilia A. Additionally, a patient-reported outcomes (PROs) assessment from the FRONTIER5 trial found that participants considered the Mim8 pen injector easy to use and generally preferred it over the Hemlibra (emicizumab) injection device they had used previously.1
Can Patients Safely Switch Directly from Hemlibra to Mim8 Without a Washout Period?
“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,” said Allison P. Wheeler, MD, Washington Center for Bleeding Disorders, Seattle, WA, in a press release. “These data demonstrate that switching to Mim8 from emicizumab can be done without requiring a washout period. 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.”
Study Design and Endpoints
- The open-label, single-arm, open-label, 26-week FRONTIER5 trial evaluated the safety of switching from Hemlibra prophylaxis treatment directly to Mim8 prophylaxis treatment in 61 adults and adolescents with hemophilia A, with or without inhibitors.
- The primary endpoint of the trial was the number of treatment-emergent adverse events (TEAEs).
- Key secondary endpoints included device handling experience using the hemophilia device handling and preference assessment (HDHPA) questionnaire as well as the change in participants’ treatment burden using the hemophilia treatment experience measure total score.1,2
Safety and Patient-Reported Outcomes
- Results show that Mim8 was well tolerated, with no new safety concerns.
- No thromboembolic events, hypersensitivity reactions, or TEAEs leading to discontinuation were reported, and no neutralizing anti-Mim8 antibodies were observed.
- Notably, the PROs assessment showed that 97% of patients preferred the Mim8 pen-injector, reporting a “very strong” or “fairly strong” preference in comparison to their previous Hemlibra injection system.
- In patients who completed the HDHPA questionnaire, 98% reported the Mim8 pen-injector “very easy” or “easy” to use.
- Ninety-five percent reported it “much easier” or “easier” compared to previous methods.
- All participants were either “extremely confident” or “very confident” in using the pen-injector correctly.
- Eighty-three percent of patients reported the dose “very easy” to inject.1
Context and Significance
These results build on previous data from Mim8 in patients with hemophilia A. In February, Novo Nordisk announced that results from the Phase III FRONTIER3 trial showed that Mim8 demonstrated zero bleeds in a majority of patients between one and 11 years of age. Similar to the FRONTIER5 trial, FRONTIER3 data showed that Mim8 was well tolerated and efficacious after 26 weeks of administration, according to trial investigators.2
Hemophilia A is the most common form of hemophilia, accounting for 80% of all cases. Its prevalence is approximately one in every 5,000 males and it affects around 40,000 males globally, many of whom remain undiagnosed.3
Executive Insights
“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 this community,” said Stephanie Seremetis, chief medical officer, CVP, hemophilia, Novo Nordisk, in the press release. “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.”
References
Novo Nordisk A/S: Mim8 prophylaxis treatment shown to be well-tolerated when switching from emicizumab in people with haemophilia A in new phase 3 data presented at the ISTH 2025 Congress. Novo Nordisk. June 22, 2025. Accessed June 26, 2025. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916355
A Research Study Looking at How Safe it is to Switch From Emicizumab to Mim8 in People With Haemophilia A (FRONTIER 5) (FRONTIER 5). Clinicaltrials.gov. Accessed June 26, 2025. https://clinicaltrials.gov/study/NCT05878938
Mim8 Demonstrates Promising Results in Pediatric Patients with Hemophilia A. PharmExec. February 10, 2025. Accessed June 26, 2025. https://www.pharmexec.com/view/mim8-demonstrates-promising-results-pediatric-patients-hemophilia-a
Hemophilia A. NIH. Accessed June 26, 2025. https://www.ncbi.nlm.nih.gov/books/NBK470265/#:~:text=Hemophilia%20A%20is%20the%20most,undiagnosed%20in%20the%20developing%20world.
