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

PR75471

ATHENS, Greece, Sept. 28, 2018 /PRNewswire=KYODO JBN/ --

    Somapacitan, a novel growth hormone derivative in development for

once-weekly administration of growth hormone, matched the therapeutic benefits

of once-daily Norditropin(R) (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(R) 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(R).

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(R). 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(R)

administration. Participants were randomised to either a dose of somapacitan

(0.04, 0.08 or 0.16 mg/kg/wk) or Norditropin(R) 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(R). The observed safety profile in

the trial was consistent with that known for Norditropin(R).[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) Savendal 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(R) FlexPro(R)) 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-deficiency.

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

Asa 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

SOURCE: Novo Nordisk