Session: SAT 109-133-GHRH, GH & IGF Biology & Signaling
Bench to Bedside
Poster Board SAT-120
Design and methods: 54 GHDA patients (46 males and 8 females) who had IGF-1 levels within ±2 SDS during daily hGH replacement were switched to MOD-4023 administered as once-weekly or every-other-week subcutaneous injections to evaluate safety, tolerability and PK/PD profile. The study was comprised of two stages. Stage I was a dose finding period in which the patients were administered MOD-4023 weekly (or every-other-weekly) for 4 weeks. Stage II was a 16 week extension period of once weekly MOD-4023 administration to collect further safety information and confirm the results obtained in Stage I. The results of Stage II are presented here.
Results: During the 16-week treatment period, most of the patients maintained IGF-1 levels within the normal range (±2 SDS). No accumulation of IGF-I was observed over the studied period. Few AEs were attributed to MOD-4023 overall, and were expected following any r-hGH treatment. Laboratory assessments, vital sign assessments, and physical examinations were unremarkable and revealed no unexpected safety concerns. Fasting glucose, fasting insulin and HbA1c were unchanged. Lipid parameters (including Lp(a) were maintained throughout the treatment period.
Conclusions: MOD-4023 once-weekly treatment was shown to be tolerable and safe in GHD adults. The data derived from this study supports long-term once-weekly dosing with this product and will be further confirmed during the pivotal phase 3 study.
Nothing to Disclose: GH, VP, MIG, PV, JP, MP, MB, LA, EF
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