Investor Presentaiton
Investor presentation
First three months of 2017
Slide 100
N8-GP administered every fourth day reduces median
bleeding rate to 1.3 episode per year in phase 3 trial
N8-GP phase 1 pharmacokinetics
FVIII activity
(IU/mL)
1.21
1.0
0.8
0.6
0.4
0.2
0.0
0
Dose 50 IU/kg (n=8)
One stage clot assay
FVIII
N8-GP
·
•
•
•
•
Pathfinder 2 headline results (phase 3)
PK documented single dose half-life of 18.4 hours and
mean trough level before next dose of 3%
Patients on every fourth day prophylaxis (50 IU/kg) had a
median ABR of 1.3
95% of mild to moderate bleeds managed with 1-2 doses
N8-GP appeared to have a safe and well tolerated profile
One patient developed inhibitors, as expected in a
population of previously treated haemophilia A patients
Pathfinder 2 extension trial results
•
55 patients with ≤2 bleeds during 6 months in the main
phase were randomised 2:1 to either once-weekly (75 IU/
kg) or every fourth day (50 IU/kg) treatment for 180 days¹
Patients in both treatment arms had a median ABR of 0
Next steps
•
•
24
48
72
Time (h)
96
120
144
168
Expansion of production capacity; US/EU submission 2018
Source: Tiede et al. J Thromb Haemot. 2013;11:670-675
changing
diabetes®
PK: Pharmacokinetic; ABR: Annualised bleeding rate; IU: International unit
1 Prophylaxis 75 IU/kg every 7 days (n=38) or prophylaxis 50 IU/kg every 4 days
(n=17)
novo nordiskView entire presentation