Novo Nordisk Publishes Phase 3b Denecimig Results in Haemophilia A

Novo Nordisk (NYSE:NVO) has published results from its phase 3b FRONTIER5 study of investigational treatment denecimig in the Journal of Thrombosis and Haemostasis, reporting safety, laboratory and patient-experience findings in people with haemophilia A.

The study examined whether patients could switch directly from emicizumab to denecimig without requiring a washout period or an initial loading dose.

The open-label trial enrolled 61 adolescents and adults aged 12 years and older with haemophilia A, including patients with and without inhibitors.

Participants were monitored over 26 weeks to assess treatment-emergent adverse events, changes in thrombin generation and their experience using the treatment’s injection device.

Study Reports Safety Findings Over 26 Weeks

The trial recorded 107 treatment-emergent adverse events across 43 patients, representing 70.5% of participants.

Most events, or 98.1%, were classified as mild to moderate.

No thromboembolic events, hypersensitivity reactions or treatment-emergent adverse events leading to treatment discontinuation were reported during the study.

The findings provide safety information on switching directly from emicizumab to denecimig, although the open-label design and 26-week observation period limit conclusions about longer-term outcomes.

Exploratory Results Show Increased Thrombin Generation

Exploratory laboratory findings showed that mean thrombin peak height increased by 78.8% from baseline across all dosing groups.

Thrombin peak height reached levels within the normal range and remained sustained throughout the 26-week study period.

Researchers reported no clinical evidence of excessive clotting during the observation period.

These laboratory results provide information about denecimig’s effect on thrombin generation but do not, on their own, establish its comparative effectiveness in preventing bleeding.

Patients Report Preference for Denecimig Injection Device

The study also evaluated patients’ experiences with the denecimig injection pen using the Hemophilia Device Handling and Preference Assessment.

Among 59 patients who completed the assessment, 98.3% described the injection pen as “easy” or “very easy” to use.

A total of 94.9% reported that the pen was easier to use than their previous administration method, while 96.6% preferred it over their prior device.

A separate assessment of treatment burden, conducted in 55 patients, showed an average reduction of 4.7 points at week 26 using the Hemophilia Treatment Experience Measure.

The average baseline treatment-burden score was 10.5 points.

These findings suggest that participants generally reported a more favourable treatment experience after switching, although the study did not include a blinded comparison group.

FDA Reviews Denecimig Application

A Biologics License Application for denecimig is currently under review by the US Food and Drug Administration.

Novo Nordisk is seeking approval for routine prophylaxis in adult and paediatric patients with haemophilia A, with or without inhibitors.

The application covers three dosing schedules: once weekly, once every two weeks and once monthly.

Denecimig remains investigational while the FDA reviews the application, and the published FRONTIER5 findings form part of the available clinical evidence concerning its safety and treatment experience.

Novo Nordisk stock price