ESPE Abstracts (2015) 84 P-3-938

GH & IGF

An Open-Label Phase 2 Dose-Finding Study Comparing Three Different Doses of Weekly TV-1106 and Daily Recombinant Human GH (Genotropin®) in Treatment-Naive, Pre-Pubertal, GH-Deficient Children

Ron G Rosenfelda, Jan M Witb, Oleg Malievskyc, Elena Bolshovad, Kurt Browne, Anat Sakovf, Gaya Anscheutzf, Merav Bassang,h & Kathleen Butlere

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aSTAT5 Consulting, LLC; Oregon Health & Science University, Portland OR, USA; bDepartment of Pediatrics, Leiden University Medical Center, Leiden, The Netherlands; cBashkir State Medical University, Ufa, Russia; dInstitute of Endocrinology and Metabolism, Kiev, Ukraine; eClinical Development Teva Pharmaceuticals, Frazer PA, USA; fBiostatistics Teva Pharmaceuticals Ltd, Netanya, Israel; gBiostatistics Teva Pharmaceuticals Ltd, West Chester PA, USA; hResearch and Development Teva Pharmaceuticals Ltd, Netanya, Israel


Background: TV-1106 (Teva Pharmaceuticals) is a genetically fused human GH and human serum albumin, in development for treatment of GH deficiency (GHD). TV-1106 has an extended duration of action compared to daily GH treatment and thus it is believed that treatment with TV-1106 can reduce the frequency of injections and improve compliance and quality of life for those requiring growth hormone replacement therapy. The efficacy and safety data from adult studies with TV-1106 support initiation of the pediatric phase 2 study.

Objective and hypotheses: The aim of the phase 2 study is to evaluate the safety and efficacy of three different weekly doses of TV-1106 and a daily dose of Genotropin as a treatment of pediatric GHD.

Method: 60 treatment-naïve pre-pubertal children with GHD will be randomized (1:1:1:1) to one of 3 doses of TV-1106 (0.554 mg/kg per week, 0.924 mg/kg per week, and 1.2 mg/kg per week) administered s.c. injection or a daily dose of Genotropin (0.033 mg/kg per day s.c. injection). The open-label study consists of four periods: screening, 6-month core study, 6-month efficacy extension, and 12-month safety extension. Primary endpoints are safety and tolerability; secondary endpoints are height velocity (HV), HV S.D. scores (HV-SDS), and height S.D. scores (H-SDS). Exploratory endpoints include IGF1 and bone maturation as measured by ratio of bone age to chronological age (BA/CA), patient adherence and quality of life outcomes.

Results: For the 24 patients currently enrolled in TV-1106 groups (0.554 0.924 and 1.2 mg/kg per week) and Genotropin group, mean peak GH level (mcg/l) at baseline are 6.7, 4.7, 1.8 and 6.7 and mean IGF1 SDS scores at baseline are −0.83, −0.7, −1.7, and −1.25 respectively. Demographics for all study participants will be presented.

Conclusion: This study will provide essential data towards understanding how once weekly administration of TV-1106 safely and effectively treats pediatric patients with GHD.

Funding: This work was supported by the Research and Development Divsion of Teva Pharmaceuticals Ltd Israel.

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