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.
The trial compared three somapacitan doses (0.04, 0.08 or 0.16 mg/kg/wk) to Norditropin 0.034 mg/kg/day. Annualized height velocity did not differ significantly for the 0.08 and 0.16 mg/kg/wk doses compared to Norditropin. The mean annualized 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.
Less disrupted lives
“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.”