Investor Presentation
79
Investor presentation First six months of 2022
Explorer 7 trial evaluated safety and efficacy of concizumab
in 132 haemophilia A and B patients with inhibitors
Concizumab binds TFPI, enabling
thrombin generation and clot formation
Concizumab
Explorer 7 trial design
VIIa
TFPI
Ха
Ха
TF
TF
Va
Blood
clot
Ila
1) Maintained OnD treatment
On-demand treatment
R
1:2
2) Concizumab prophylaxis
Prophylaxis treatment
(continued from phase 2)
3) Concizumab prophylaxis
Extension with
concizumab
prophylaxis
Prophylaxis treatment
4) Concizumab prophylaxis
(+ additional OnD patients)
Main part
32 weeks¹
Extension part
136 weeks
Trial Objective
Assess the efficacy of concizumab prophylaxis vs no prophylaxis in reducing number of bleeding
episodes in adults and adolescents with haemophilia A and B with inhibitors
•
Primary endpoint
Number of treated bleeding episodes from start of treatment to the end of the main phase
1At least 24 weeks for arm 1
TF: Tissue factor; TFPI: Tissue factor pathway inhibitor; OnD: On-demand: R: Randomisation
Key inclusion criteria
Males ≥12 years with haemophilia and
inhibitors, treated with bypassing agents
within last 24 weeks
For on-demand, minimum six bleeding
episodes within last 24 weeks
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