Investor Presentation H1 2023
89
Investor presentation
First six months of 2023
Interim data from Mim8 phase 1/2 show that PK/PD profiles
support weekly to monthly low volume dosing
Mim8 pharmacokinetic properties support
weekly and monthly dosing
Higher potency of Mim8 vs emicizumab
enabling a low dosing volume
Mim8 concentration (μg/mL)
10
0.1
0.01
1
0.001
07 14 21 28 35 42 49 56 63 70 77 84 91
Days
-
Cohort 1 1.2mg QW
Cohort 2 3.8mg QW
Peak thrombin (nmol/L)
300
200
100
0.01
0.1
1
15-fold
10
100
1000
Drug plasma concentration (μg/mL)
O Cohort 3 - 15mg QW
Cohort 5- 35mg QW
Cohort 4 - 60mg QM
Mim8 in-vitro
Emicizumab in-vitro
•
Mim8 concentration profiles increased with dose
•
The PD marker, peak thrombin generation, increased with Mim8 dose
•
Mean concentrations at steady state were comparable for Cohort
•
3 (weekly dosing) and Cohort 4 (monthly dosing)
In-vitro exposure-response curves in haemophilia A-like plasma show a
15-fold higher potency of Mim8 compared to emicizumab
The peak thrombin plot represents in-vitro data: human plasma samples from the healthy participants of the SAD cohort were made HA-like with anti-FVIII antibodies, and spiked with different concentrations of Mim8 or commercially available emicizumab.
PK: Pharmacokinetics; PD: Pharmacodynamics; QW: Once-weekly; QM: once-monthly
Reference: FRONTIER 1, 12-week main phase cohort 1-5. Chowdary P, et al. FRONTIER1: A Phase 1/2 Dose Escalation Study of a Novel Factor VIIIa Mimetic Bispecific Antibody, Mim8, for Evaluation of Safety, Pharmacokinetics, and Efficacy. Abstract presented at
ISTH 2022; Windyga J, et al. Mim8 is associated with improved thrombin generation vs. emicizumab in patients with haemophilia A, with and without inhibitors. Abstract presented at ISTH 2022; Novo Nordisk data on file
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