Background: Recombinant human GH (rhGH) therapy requires daily s.c. injections, this inconvenient treatment regimen results to poor compliance of the patient. Thus, to improve patient compliance, long-acting rhGH products including various protein fusion techniques have been in development during past 15 years.
Objective and hypotheses: In this study, we describe the pharmacokinetics and efficacy of a novel long-acting GH using Fc fusion protein (rhGH-Fc) in animal study.
Method: The pharmacokinetics and pharmacodynamics of rhGH-Fc were assessed in male SD rats and hypophysectomized rats.
Results: A single s.c. injection dose of 1.0 mg/kg of rhGH-Fc had a slower absorption phase, greater Cmax, and remained significantly elevated for at least 710 days compared with daily s.c. injection dose of 0.2 mg/kg of rhGH in S.D. rats. In efficacy study, there were no significant differences between rhGH (daily dose of 15 μg/animal for 14 days and rhGH-Fc (weekly dose of 240 μg/animal for 14 days with a dosing interval of a week) in hypophysectomized rats, as assessed by changes in body weight and the width of the tibial growth plate.
Conclusion: rhGH-Fc may provide the potentiality that one of the novel long-acting rhGH products will be administered up to weekly form. Further evaluation including measurements of anti-rhGH-Fc antibody titer in animal and human, and study for other safety problems such as injection-site lipoatrophpy should be needed.
01 - 03 Oct 2015
European Society for Paediatric Endocrinology