Mim8 - (FRONTIER5)

September 17, 2026: Novo Nordisk reported publication in the Journal of Thrombosis and Haemostasis of Phase 3b FRONTIER5 results for investigational denecimig in haemophilia A patients aged 12+ with or without inhibitors who switched directly from emicizumab. In the 26-week open-label study, 61 patients completed treatment without a washout period or denecimig loading dose. The primary safety analysis found 107 treatment-emergent adverse events in 43 patients (70.5%); 98.1% were mild to moderate, and 24 events were possibly/probably related to denecimig. No thromboembolic events, hypersensitivity reactions, discontinuations due to TEAEs, or clinical evidence of neutralizing anti-denecimig antibodies were observed.

Supportive secondary endpoints showed strong device preference: among 59 patients, 98.3% rated the denecimig pen “easy” or “very easy” to use, 94.9% said it was easier than prior administration, and 96.6% preferred it. Treatment burden fell by a mean 4.7 points on Hemo-TEM at week 26 (n=55). Exploratory data showed thrombin generation increased into the normal range and remained sustained through 26 weeks without evidence of excessive clotting; denecimig reached steady state by week 16 without a loading dose. A BLA is under FDA review for routine prophylaxis in adult and pediatric haemophilia A patients with or without inhibitors across weekly, every-two-weeks, or monthly dosing.