Novo Nordisk (NYSE: NVO) published phase 3b results from its FRONTIER5 study of investigational denecimig in the Journal of Thrombosis and Haemostasis, showing that patients with haemophilia A could switch directly from emicizumab to denecimig without a washout period or loading dose.

The open-label study enrolled 61 adolescents and adults aged 12 and older with haemophilia A, with or without inhibitors. Over 26 weeks, 107 treatment-emergent adverse events (TEAEs) were observed in 43 patients (70.5%), most of which were mild to moderate (98.1%). No thromboembolic events, hypersensitivity reactions, or TEAEs leading to discontinuation were observed.

Exploratory results showed thrombin peak height increased by a mean of 78.8% from baseline across all dosing arms, reaching levels within the normal range and remaining sustained over 26 weeks, with no clinical evidence of excessive clotting.

Among 59 of the 61 enrolled patients, 98.3% rated the denecimig injection pen as "easy" or "very easy" to use, 94.9% found it easier than their previous method, and 96.6% preferred it over their prior device, as measured by the Hemophilia Device Handling and Preference Assessment.

A separate endpoint measured in 55 patients showed denecimig reduced treatment burden by an average of 4.7 points at week 26, based on the Hemophilia Treatment Experience Measure, from a baseline score of 10.5.

A Biologics License Application for denecimig is currently under review with the U.S. Food and Drug Administration for use as routine prophylaxis in adult and pediatric patients with haemophilia A, with or without inhibitors, across once-weekly, once-every-two-weeks, and once-monthly dosing frequencies.