Novo Nordisk has released findings from the phase 3b FRONTIER5 trial, which demonstrate that a direct switch to investigational Mim8 (denecimig) prophylaxis from emicizumab treatment is well-tolerated in adults and adolescents with haemophilia A. The study showed no safety concerns and did not require a washout period or Mim8 loading dose. These results were presented at the International Society on Thrombosis and Haemostasis (ISTH) Congress in Washington, D.C.
The trial involved 61 participants aged 12 years and older. The first Mim8 maintenance dose was administered on the next planned emicizumab dosing day, with options for once-monthly, bi-weekly, or weekly dosing frequencies. By Week 16, steady-state Mim8 concentration was achieved, while emicizumab elimination completed by Week 26.
“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,” said Allison P. Wheeler, MD of the Washington Center for Bleeding Disorders.
The Patient-Reported Outcomes (PROs) assessment highlighted a strong preference for the Mim8 pen-injector over the previous emicizumab injection system. “These results give valuable insights into haemophilia A management,” stated Stephanie Seremetis, chief medical officer at Novo Nordisk.
Novo Nordisk plans to submit Mim8 for regulatory review during 2025. Data from ongoing studies will be shared at future congresses and publications.
Haemophilia is an inherited disorder affecting blood clotting due to missing or defective clotting factors. Haemophilia A involves Factor VIII deficiency and can lead to inhibitor development in severe cases.
Mim8 aims to provide improved potency and efficacy across flexible dosing intervals as an investigational FVIIIa mimetic bispecific antibody.
Novo Nordisk is a global healthcare company focused on defeating chronic diseases through scientific breakthroughs and expanding access to medicines.
