Endocrine Abstracts

Introduction: OPKO Biologics has produced a long-acting human growth hormone (hGH), MOD-4023, containing three copies of a naturally-occurring peptide (C-terminal peptide, CTP) that markedly increases growth hormone’s in vivo residence. We describe the development and validation of a pharmacokinetic (PK) and pharmacodynamic (PD) model to characterize the relationship between MOD-4023 dose, serum concentrations (Cserum), and IGF-1 responses in healthy adults, GHD adults, a...

Objective: Growth hormone (GH) replacement therapy currently requires daily injections. This may cause poor compliance, inconvenience and distress for patients. CTP-modified hGH (MOD-4023) has been developed for once-weekly administration in growth hormone deficient (GHD) adults and children. The 18 and 24 month efficacy of once-weekly subcutaneous (SC) administration of MOD-4023 was evaluated in a Phase 2 study in children with GH deficiency.Design and ...

Objective: Growth hormone (GH) replacement therapy currently requires daily injections. This may cause poor compliance, inconvenience and distress for patients. CTP-modified human GH (MOD-4023) has been developed for once-weekly administration in growth hormone-deficient (GHD) adults and children. In the present Phase 2 study, the safety and tolerability of once-weekly subcutaneous (SC) administration of MOD-4023 were evaluated in GHD children.Design and...