Novo Nordisk presents long-term hemophilia A data at ISTH Congress

Novo Nordisk has presented new interim data from the Phase 3 FRONTIER4 extension study evaluating the long-term safety and efficacy of investigational denecimig (Mim8) in patients with hemophilia A. The results, which included various dosing frequencies and patient ages, were presented at the International Society on Thrombosis and Haemostasis (ISTH) Congress in Paris.

The interim analysis of safety data from the FRONTIER4 study showed denecimig to be consistent with previous findings. Injection site reactions were reported at low rates and were mild and transient. No evidence of neutralizing antibodies was observed. Efficacy endpoints, measured by annualized bleeding rates (ABRs), were consistent across all dosing regimens and regardless of inhibitor status. Approximately 71% of adults and adolescents, and 89% of children, experienced zero treated bleeds while on denecimig prophylaxis.

The study involved 426 participants aged 1 year and older with hemophilia A. Longer-term patient-reported outcomes (PROs) indicated sustained improvements in joint pain and reduced treatment burden. Separately, Novo Nordisk also presented data from the concizumab explorer10 trial, showing an 82% reduction in annualized bleeding rates in children younger than 12 with hemophilia A or B with inhibitors compared to on-demand treatment.

Novo Nordisk has submitted denecimig for review to the U.S. Food and Drug Administration (FDA). The company continues to evaluate its hemophilia portfolio through ongoing clinical trials and data presentations.