ESPE Abstracts (2015) 84 P-2-450

Pharmacokinetics and Efficacy of a Long-Acting Human GH with Fc Fusion Protein

Sujin Kima, Dong-Kyu Jinb, Sungyoon Chob, Rimm Huhb, Jinsup Kimb, Aram Yangb & Hyunhee Kwakc

aDepartment of Pediatrics, Myongji Hospital, Goyang, Republic of Korea; bDepartment of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; cBiopharmaceutical Research Laboratory, Dong-A Pharm. Co. Ltd., Yongin, Republic of Korea

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 7–10 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.

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