ESPE Abstracts (2018) 89 RFC4.5

12-Month Effects of Once-Weekly and Twice-Monthly Administration of Hybrid Fc-Fused Human Growth Hormone, GX-H9, Treatment in Pediatric with GHD Deficiency

Oleg Malievskiya, Aryaev Mykolab, Zelinska Nataliyac, Elena V Bolshovad, Ganna Senatorovae, György Oroszlánf, Julia Skorodokg, Valentina Peterkovah, Chorna Nataliyai, Tamila Sorokmanj, Seung Yangk, Ji Eun Leel, Agota Muzsnaim, Jin Soon Hwangn, Sang Yoon Leeo, Yun Jung Choio, Hyi-Jeong Jip, Jungwon Woop & Young-Chul Sungp

aBashkir State Medical University, Ufa, Russian Federation; bOdessa National Medical University, Odessa, Ukraine; cUkrainian Scientifically Practical Center of Endocrine Surgery and Transplantation of Endocrine Organs and Tissues, Kyev, Ukraine; dInstitute of Endocrinology and Metabolism Named after Komisarenko NAMS of Ukraine, Kyev, Ukraine; eKharkiv National Medical University, Kharkiv, Ukraine; fMarkusovszky University Hospital, Szombathely, Hungary; gSt. Petersburg State Pediatric Medical University, St. Petersburg, Russian Federation; hInstitute of Pediatric Endocrinology, Moscow, Russian Federation; iRegional Clinical Children’s Hospital, Ivano-Frankivsk, Ukraine; jBukoinian State Medical University, Chernivtsi, Ukraine; kKangdong Sacred Heart Hospital, Seoul, Republic of Korea; lInha University Hospital, Incheon, Republic of Korea; mSt. John’s Hopital and United Hospitals of Northern Buda, Budapest, Hungary; nAjou University School of Medicine, Ajou University Hospital, Suwon, Republic of Korea; oHANDOK, Inc., Seoul, Republic of Korea; pGenexine, Inc., Seongnam, Republic of Korea.

GX-H9 is a long-acting form of recombinant human GH under clinical development for both adults and children with GH deficiency (GHD). This study was designed to compare 12-month effects of once-weekly and twice-monthly (every other week; EOW) administration of GX-H9 treatment to that of Genotropin®, in pediatric patients with GHD. A randomized, open-label, active-controlled, parallel study was conducted at 27 endocrinology centers in 10 countries (Europe and Korea). Subjects were randomly assigned to receive either one of the three doses of GX-H9 (0.8 mg/kg per weekly, 1.2 mg/kg per weekly or 2.4 mg/kg per EOW) or 0.03 mg/kg per daily of Genotropin® for up to 24 months. Among fifty-six pediatric GH naïve GHD subjects randomized, six subjects withdrew from the study, and remaining 50 subjects were treated longer than 12 months. The annualized height velocity (aHV) at 12 months of treatment were comparable between all doses of GX-H9 and Genotropin® (10.65, 11.76, 11.48 and 9.07 cm/year; 0.8 mg/kg, 1.2 mg/kg weekly, 2.4 mg/kg twice-monthly and 0.03 mg/kg per daily Genotropin®, respectively). No significant slowdown of growth rate was observed after 12 months of GX-H9 or Genotropin® treatment compared to aHV calculated after first 6 months of treatment. Height SDS improved steadily from baseline to 6 and 12 months of GX-H9 or Genotropin® treatments (change from baseline, after 6 and 12 months of treatment: 0.66 SDS and 1.15 SDS, 0.66 SDS and 1.37 SDS, 0.69 SDS and 1.14 SDS, 0.70 SDS and 0.85 SDS; 0.8 mg/kg, 1.2 mg/kg weekly, 2.4 mg/kg twice-monthly and 0.03 mg/kg per daily Genotropin®, respectively). Pre and post body mass index SDS were comparable throughout the 12 months of treatment period for all GX-H9 doses and Genotropin® (change from Baseline:+0.44 SDS, +0.11 SDS, −0.18 SDS, −0.24 SDS; 0.8 mg/kg, 1.2 mg/kg weekly, 2.4 mg/kg twice-monthly and 0.03 mg/kg/daily Genotropin®, respectively). No lipoatropy or injection site nodule formation or insulin resistance was observed in this study. Safety profiles were comparable across the treatment groups and with Genotropin®. Twelve-month effects of once-weekly, twice-monthly administration of GX-H9 and daily Genotropin® were comparable with no significant slowdown of growth rate compared to first 6 months. Long term safety profiles were similar to that of Genotropin®.

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