Le Centre Hospitalier Universitaire de Toulouse

Novo Nordisk presented positive findings from a late-stage basket study of once-weekly Sogroya (somapacitan) at the joint congress of the European Society for Paediatric Endocrinology (ESPE) and the European Society of Endocrinology (ESE) on Monday, bolstering the growth hormone analogue’s label expansion filings in the US and EU for certain paediatric growth disorders.Specifically, Sogroya demonstrated clinical non-inferiority to once-daily Norditropin (somatropin) in pre-pubertal children born small for gestational age (SGA), or with Noonan syndrome (NS), or idiopathic short stature (ISS). The drug also showed superiority over Norditropin in children with NS and against lower doses of Norditropin in children born SGA.Highlighting the cumulative negative impact of regularly missing doses of growth hormone, Martin Lange, Novo’s executive VP for development, said: “​We are committed to providing…therapies with flexibility in administration timing and missed doses, which may better suit the needs of children with growth failure.”The Phase III REAL8 trial — part of the broader REAL programme — employed a basket design to evaluate once-weekly Sogroya across four paediatric growth disorders — SGA, NS, ISS and Turner syndrome (TS). Children with NS, TS, or ISS were randomised to receive either weekly Sogroya or daily Norditropin, while those with SGA were assigned to Sogroya, or two different Norditropin doses — lower and higher than the standard dose.Results showed the study achieved its primary endpoints across three indications. In children born SGA, Sogroya demonstrated superior estimated mean height velocity compared with a lower dose of Norditropin (11.0 vs 9.4 cm/year) and non-inferior results compared with a higher dose (11.0 vs 11.1 cm/year). In children with NS, Sogroya showed superior results (10.4 vs 9.2 cm/year), while in those with ISS, it demonstrated non-inferiority (10.5 vs 10.5 cm/year) compared with Norditropin.Meanwhile, the weekly therapy showed no safety and tolerability issues compared with the daily formulation, with similar insulin-like growth factor 1 responses observed across treatment groups. Novo noted that based on the data from REAL8 and another ongoing study REAL9, it submitted marketing applications with the FDA and the EMA for the three indications last month. Results from the TS participants are expected later this year.Sogroya is currently approved to treat growth failure due to inadequate secretion of endogenous growth hormone in children aged 2.5 years and above and as a replacement for endogenous growth hormone in adults with growth hormone deficiency.