Somapacitan,once-weekly growth hormone derivative, showed in REAL 3, comparable efficacy, safety and tolerability to once-daily injections of Norditropin. Novo Nordisk

Novo Nordisk announced that somapacitan, a novel growth hormone derivative in development as a once-weekly treatment option, demonstrated comparable efficacy, safety and tolerability to once-daily injections of Norditropin (somatropin) after one year, with improved efficacy seen at the highest dose of somapacitan .

The data, from the REAL 3 paediatric phase II trial in children with growth hormone deficiency (GHD), were presented today by Professor Lars S�vendahl at the 58th Annual Meeting of the European Society for Paediatric Endocrinology (ESPE). The REAL 3 trial compared three different weekly somapacitan doses (0.04, 0.08 or 0.16 mg/kg/week) to daily somatropin (0.034 mg/kg/day) in children with GHD. The 1-year results supported the previously-reported 6-month data, with the new finding at one year that mean standard deviation (SD) annualised height velocity (HV, cm/year) was statistically significantly higher with somapacitan 0.16mg/kg/week compared to daily somatropin. HV for the three doses of somapacitan was 7.8, 9.7 and 11.5 cm/year, respectively, compared to 10.0 cm/year for once-daily somatropin.

About the REAL 3 main trial and extension phase REAL 3 is a multinational, randomised, parallel-group, active-controlled trial evaluating the efficacy of three different doses of once-weekly somapacitan after 26 weeks and 52 weeks of treatment in 59 growth hormone treatment-na�ve pre-pubertal children with GHD, compared to daily Norditropin (somatropin) administration. Participants were randomised to either a dose of somapacitan (0.04, 0.08 or 0.16 mg/kg/week) or somatropin 0.034 mg/kg/day. The REAL 3 trial has an ongoing extension period of up to 312 weeks.