New Phase 2 Data for Somapacitan Demonstrate Its Potential as an Efficacious Once-weekly Treatment for Childhood Growth Hormone Deficiency

Athens, Greece (ots/PRNewswire) -

Somapacitan, a novel growth hormone derivative in development for
once-weekly administration of growth hormone, matched the therapeutic
benefits of once-daily Norditropin® (somatropin) in a phase 2 trial
in children with growth hormone deficiency.[1] There are currently no
approved once-weekly treatments for growth hormone deficiency. The
REAL 3 trial data were presented today at the 57th Annual Meeting of
the European Society for Paediatric Endocrinology in Athens, Greece.

The trial compared three somapacitan doses (0.04, 0.08 or 0.16
mg/kg/wk) to Norditropin® 0.034 mg/kg/day. Annualised height velocity
did not differ significantly for the 0.08 and 0.16 mg/kg/wk doses
compared to Norditropin®. The mean annualised height velocity for the
three dose levels of somapacitan was 8.0 cm, 10.9 cm and 12.9 cm,
respectively, as compared to 11.4 cm for daily Norditropin®.
Somapacitan was well tolerated at all doses investigated, with no
clinically relevant safety or local tolerability issues
identified.[1]

"Today children with growth hormone deficiency require daily
injections, which can be a considerable treatment burden for patients
and caregivers. A once-weekly treatment would represent a significant
development for these children and their families, helping them to
live less disrupted lives," said lead investigator Prof Lars
Sävendahl of the Karolinska Institutet and Pediatric Endocrinology
Unit, Karolinska University Hospital, Stockholm, Sweden.

"The injection fatigue following years of daily administration
could negatively impact adherence, thereby leading to worse treatment
outcomes," said Mads Krogsgaard Thomsen, executive vice president and
chief science officer of Novo Nordisk. "In line with our long-term
commitment, we are investigating the potential of somapacitan as a
once-weekly growth hormone treatment for children with growth hormone
deficiency."

About the REAL 3 trial

REAL 3 was a multinational, randomised, parallel-group,
active-controlled trial with the primary endpoint to evaluate the
efficacy of multiple dose regimens of once-weekly somapacitan after
26 weeks of treatment in 59 growth hormone treatment-naïve
pre-pubertal children with growth hormone deficiency, compared to
daily Norditropin® administration. Participants were randomised to
either a dose of somapacitan (0.04, 0.08 or 0.16 mg/kg/wk) or
Norditropin® 0.034 mg/kg/day. The trial demonstrated dose dependency
with no statistically significant difference in height velocity
between somapacitan and daily growth hormone at the two upper doses
of somapacitan. The mean annualised height velocity for the three
dose levels of somapacitan was 8.0 cm, 10.9 cm and 12.9 cm,
respectively, as compared to 11.4 cm for daily Norditropin®. The
observed safety profile in the trial was consistent with that known
for Norditropin®.[1,2]

About somapacitan

Somapacitan is a long-acting analogue of human growth hormone
which is under investigation as a possible treatment for growth
hormone deficiency. Somapacitan is built on the near twenty year-long
protein technology applied for prolongations of insulins, GLP-1 and
now growth hormone. Somapacitan has been modified from native human
growth hormone to increase its binding to the plasma protein albumin,
making it suitable for once-weekly dosing.[3]

About childhood growth hormone deficiency

Childhood growth hormone deficiency is a rare condition in which
there is not enough growth hormone circulating in the blood to ensure
normal growth. Affected children experience slowed or halted growth
from the age of two to three years onwards. If treatment is started
early, affected children may grow to a normal height. Currently
available growth hormone treatments must be administered as a daily
subcutaneous injection.[4-6]

About Novo Nordisk

Novo Nordisk is a global healthcare company with 95 years of
innovation and leadership in diabetes care. This heritage has given
us experience and capabilities that also enable us to help people
defeat obesity, haemophilia, growth disorders and other serious
chronic diseases. Headquartered in Denmark, Novo Nordisk employs
approximately 43,100 people in 79 countries and markets its products
in more than 170 countries. For more information, visit
novonordisk.com (https://www.novonordisk.com/), Facebook
(http://www.facebook.com/novonordisk), Twitter
(http://www.twitter.com/novonordisk), LinkedIn
(http://www.linkedin.com/company/novo-nordisk), YouTube
(https://www.youtube.com/user/novonordisk/custom).

References

1. Sävendal L, Rasmussen MH, Horikawa R, et al. Efficacy and safety
of once-weekly somapacitan in childhood growth hormone deficiency:
results of a randomised open-label, controlled phase 2 trial.
Presented at the 57th Annual Meeting of the European Society for
Paediatric Endocrinology, Athens, Greece. 27-29 September 2018.
2. Clinicaltrials.gov. Investigating Efficacy and Safety of
Once-weekly NNC0195-0092 (Somapacitan) Treatment Compared to Daily
Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone
Treatment naïve Pre-pubertal Children With Growth Hormone
Deficiency. Available online at
https://clinicaltrials.gov/ct2/show/NCT02616562. Last accessed
July 2018.
3. Battelino T, Rasmussen MH, De Schepper J, et al. Somapacitan, a
once-weekly reversible albumin-binding GH derivative, in children
with GH deficiency: A randomized dose-escalation trial. Clin
Endocrinol (Oxf). 2017;87:350-358.
4. Murray PG, Dattani MT, Clayton PE. Controversies in the diagnosis
and management of growth hormone deficiency in childhood and
adolescence. Arch Dis Child. 2016;101:96-100.
5. Great Ormond Street Hospital For Children. Growth Hormone
Deficiency. August 2014. Available online at https://www.gosh.nhs.
uk/conditions-and-treatments/conditions-we-treat/growth-hormone-de
ficiency. Last accessed July 2018.
6. Polak M, Blair J, Kotnik P, et al. Early growth hormone treatment
start in childhood growth hormone deficiency improves near adult
height: analysis from NordiNet(R) International Outcome Study. Eur
J Endocrinol. 2017;177:421-429.

Further information

Media:

Katrine Sperling

+45-4442-6718

krsp@novonordisk.com

Åsa Josefsson

+45-3079-7078

aajf@novonordisk.com

Investors:

Peter Hugreffe Ankersen

+45-3075-9085

phak@novonordisk.com

Anders Mikkelsen

+45-3079-4461

armk@novonordisk.com

Valdemar Borum Svarrer

+45-3079-0301

jvls@novonordisk.com

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