medwireNews: Data from a dose-escalation study of the long-acting growth hormone (GH) somapacitan support its further development as a weekly treatment in children with GH deficiency (GHD), say researchers.
The medication, which is currently being tested in a phase III trial in adults and a phase II trial in children, reversibly binds to endogenous albumin, resulting in an extended half-life. This method of extending a medication’s half-life is already in use for some approved diabetes treatments, note Michael Højby Rasmussen (Novo Nordisk A/S, Bagsvaerd, Denmark) and study co-authors.
In the current study, 32 children with confirmed GHD, aged a median of 9 years, were randomly assigned in a 3:1 ratio to receive one of four somapacitan doses or standard daily GH treatment (somatropin; 0.03 mg/kg). They discontinued their previous GH treatment for 7–10 days before receiving the study medications: one dose of somapacitan or seven daily doses of standard GH treatment.
Adverse events were all mild, and were mostly single events that occurred in one or two children and considered unrelated to the study treatment. Four mild and transient injection-site reactions occurred in three children, all of whom received the highest dose of 0.16 mg/kg and were therefore given it as two injections to reduce the volume (only one concentration of somapacitan was available).
The other somapacitan doses were 0.02, 0.04 and 0.08 mg/kg, and the research team detected a dose-dependent association with insulin-like growth factor (IGF)-1 response. Average IGF-1 levels remained within the normal range throughout the 7 days after treatment; the largest change in IGF-1 standard deviation score occurred among patients given the 0.16 mg/kg dose, from –2.5 at baseline to +1.0 at day 3.
The IGF-1 response at the three highest somapacitan doses was not significantly different to that seen for daily GH treatment.
“The IGF-1 profile indicates that somapacitan is suitable for once-weekly dosing in children with GHD”, the researchers write in Clinical Endocrinology, noting that there was also a dose response for levels of IGF-binding protein-3.
By Eleanor McDermid
Clin Endocrinol 2017; Advance online publication
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