Mim8 Shows Promise for Hemophilia A Treatment
A new study shows promising results for a potential new treatment for those with hemophilia A. The investigational drug Mim8 appears to be safe and well-tolerated. It also offers a user-friendly experience for patients who switch from emicizumab.
Direct Switch Proves Safe
Data from the FRONTIER5 trial reveal that adults and adolescents with hemophilia A can switch directly to Mim8 (denecimig) prophylaxis. This switch from emicizumab treatment can be done without a washout period. The study, which involved subjects with and without inhibitors, showed no safety issues.
Switching to Mim8 led to an increase in thrombin generation. However, it did not cause potentially dangerous thrombin levels. The Mim8 pen-injector was easy to use, and patients preferred it over the emicizumab injection system, according to patient-reported outcomes.
“Continuous prophylactic coverage is critical to avoiding breakthrough bleeds in people living with haemophilia; 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,”
—Allison P. Wheeler, MD, Washington Center for Bleeding Disorders, Seattle, WA
The open-label phase 3b FRONTIER5 trial included 61 individuals aged 12 years and older. Mim8 was well-tolerated, and no safety concerns emerged. The study found no thromboembolic events or hypersensitivity reactions. Also, there was no evidence of neutralizing anti-Mim8 antibodies.
Patient Preference High
Around 97% of patients expressed a strong preference for the Mim8 pen-injector. The Haemophilia Device Handling and Preference Assessment (HDHPA) questionnaire revealed that 98% found the device easy to use. Plus, 95% found it much easier compared to their previous administration method. The study’s participants were very confident in using the pen-injector correctly.
“The FRONTIER5 safety and patient-reported outcomes data support Mim8 as a potential future treatment option for people living with haemophilia A and demonstrate our continued commitment to developing innovative treatment options for this community”, said Stephanie Seremetis, chief medical officer and CVP for Haemophilia at Novo Nordisk. “These results give valuable insights into haemophilia A management, highlight the feasibility of directly switching to Mim8 from emicizumab, and reveal a strong patient preference for the Mim8 pen-injector device.”
Understanding Hemophilia A
Hemophilia A is an inherited bleeding disorder. It prevents the body from forming blood clots. This condition affects around 1,125,000 people globally. The disease is caused by a missing or defective clotting Factor VIII (FVIII). According to the World Federation of Hemophilia, approximately 400,000 people worldwide are living with severe forms of the condition.
Mim8 is a bispecific antibody designed to mimic FVIIIa. It aims to provide improved potency across flexible dosing intervals for those with hemophilia A. Administered subcutaneously, it helps blood clot by bridging Factor IXa and Factor X.
Novo Nordisk anticipates submitting Mim8 for regulatory review in 2025. Data from the ongoing FRONTIER program will be revealed at upcoming congresses and in publications during 2025 and 2026. The FRONTIER5 trial evaluated the safety of directly switching to Mim8 prophylaxis from emicizumab prophylaxis.