Long-acting FC-fusion rhGH (GX-H9) shows potential for up to twice-monthly administration in GH-deficient adults - Aix-Marseille Université Access content directly
Journal Articles European Journal of Endocrinology Year : 2018

Long-acting FC-fusion rhGH (GX-H9) shows potential for up to twice-monthly administration in GH-deficient adults

Cheol Ryong Ku
  • Function : Author
Katharina Schilbach
  • Function : Author
Stanislav Ignatenko
  • Function : Author
Sandor Magony
  • Function : Author
Yoon-Sok Chung
  • Function : Author
Byung-Joon Kim
  • Function : Author
Kyu Yeon Hur
  • Function : Author
Ho-Cheol Kang
  • Function : Author
Jung Hee Kim
  • Function : Author
Min Seon Ki
  • Function : Author
Aldona Kowalska
  • Function : Author
Marek Bolanowski
  • Function : Author
Marek Ruchala
  • Function : Author
Svetozar Damjanovic
  • Function : Author
Juraj Payer
  • Function : Author
Yun Jung Choi
  • Function : Author
Su Jin Heo
  • Function : Author
Tae Kyoung Kim
  • Function : Author
Minkyu Heo
  • Function : Author
Joan Lee
  • Function : Author
Eun Jig Lee
  • Function : Author

Abstract

Objective: Hybrid Fc-fused rhGH (GX-H9) is a long-acting recombinant human growth hormone (GH) under clinical development for both adults and children with GH deficiency (GHD). We compared the safety, pharmacokinetics and pharmacodynamics of weekly and every other week (EOW) dosages of GX-H9 with those of daily GH administration in adult GHD (AGHD) patients. Design: This was a randomized, open-label, active-controlled and dose-escalation study conducted in 16 endocrinology centers in Europe and Korea. Methods: Forty-five AGHD patients with or without prior GH treatment were enrolled. Patients with prior GH treatments were required to have received the last GH administration at least 1 month prior to randomization. Subjects were sequentially assigned to treatment groups. Fifteen subjects were enrolled to each treatment group and randomly assigned to receive either GX-H9 or Genotropin (4:1 ratio). GX-H9 dosage regimens for Groups 1, 2 and 3 were 0.1 mg/kg weekly, 0.3 mg/kg EOW and 0.2 mg/kg EOW, respectively. All Genotropin-assigned subjects received 6 mu g/kg Genotropin, regardless of treatment group. Main outcome analyses included measurements of serum insulin-like growth factor 1 (IGF-I), safety, pharmacokinetics, pharmacodynamics and immunogenicity. Results: Mean GX-H9 peak and total exposure increased with an increase in dose after a single-dose administration. The mean IGF-I response was sustained above baseline over the intended dose interval of 168 h for the weekly and 336 h for the EOW GX-H9 groups. Safety profiles and immunogenicity were not different across the treatment groups and with Genotropin. Conclusions: GX-H9 has the potential for up to twice-monthly administration.

Domains

Human genetics
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Dates and versions

hal-01991346 , version 1 (23-01-2019)

Identifiers

  • HAL Id : hal-01991346 , version 1

Cite

Cheol Ryong Ku, Thierry Brue, Katharina Schilbach, Stanislav Ignatenko, Sandor Magony, et al.. Long-acting FC-fusion rhGH (GX-H9) shows potential for up to twice-monthly administration in GH-deficient adults. European Journal of Endocrinology, 2018, 179 (3), pp.169-179. ⟨hal-01991346⟩

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