Full Year 2023 Investor Presentation slide image

Full Year 2023 Investor Presentation

89 Investor presentation Full year 2023 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 Main 26 weeks 26 weeks Trial design • • Novel and accelerated design minimising time from phase 2 into phase 3. Dosing started 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, was initiated in Q4 2022 HA, haemophilia A; HAWI, haemophilia A with inhibitors; PPX, Prophylaxis; QM, monthly dosing; QW, weekly dosing
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