Investor Presentaiton
89
Investor presentation
Full year 2022
SogroyaⓇ phase 3 trial successfully completed with aspirational
target product profile achieved
Phase 3a trial results in children with GHD
ETD (95% CI) = -0.5 (-1.1; 0.2)
Efficacy
Key highlights
Height velocity (cm/year)
12.5
11.7
10.0
7.5
5.0
2.5
0.0
NorditropinⓇ
.
Non-inferiority versus Norditropin® for the primary endpoint, height
velocity, at week 52 was confirmed
11.2
•
IGF-I SDS, bone age and glucose metabolism were all similar
between somapacitan and NorditropinⓇ
Safety and tolerability
•
Overall the safety profile of somapacitan appeared to be similar to
the well-known safety profile of daily GHD treatment
•
No local tolerability issues were identified
Other treatment parameters
•
Significantly reduced treatment burden¹ compared to Norditropin®
Next steps
•
Submission took place in Q2 2022
somapacitan
1 Measured using patient reported outcome TB-CGHD-P (Treatment burden measure - child growth hormone deficiency - parent)
ETD: Estimated treatment difference; IGF-I SDS: Insulin growth factor-1 standard deviation score; GHD: Growth hormone deficiency; IGF-I SDS: Insulin growth factor-1 standard deviation score
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