Investor Presentation First Nine Months of 2022
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Investor presentation
First nine months of 2022
The pivotal phase 3 trial with Mim8 was initiated in Q4 2022
Novo NordiskⓇ
FRONTIER 2: Mim8 phase 3 pivotal trial in ~260 adults & adolescents
No PPX
No PPX
HA + HAWI
R
Mim8 PPX QW
1:1:1
Mim8 PPX QM
Mim8 PPX QW/QM
Mim8 PPX QW
Mim8 PPX QM
Coagulation
Mim8 PPX QW
factor PPX
R
HA + HAWI
Mim8 PPX QM
Mim8 PPX QW
Mim8 PPX QM
1:1
Run-in (PPX only)
26-52 weeks
Extension
Trial design
•
•
Main
26 weeks
.
26 weeks
Novel and accelerated design minimising time from phase 2 into
phase 3 with phase 3 dosing starting in Q4 2022
Testing of weekly and monthly Mim8 prophylaxis treatment for
previously on-demand or coagulation factor prophylaxis patients
Trial objective
On demand: Superiority of Mim8 prophylaxis vs no prophylaxis
Prophylaxis: Superiority of Mim8 prophylaxis vs coagulation factor
prophylaxis run-in period
Key trial endpoints
ABR for treated bleeds over 26 weeks of treatment
Overall safety of Mim8 prophylaxis including occurrence of anti-
Mim8 antibodies and injection site reactions
The second phase 3a trial, FRONTIER3, is expected to initiate treatment
with Mim8 in the coming months
HA, haemophilia A; HAWI, haemophilia A with inhibitors; PPX, Prophylaxis; QM, monthly dosing; QW, weekly dosingView entire presentation