hrp0082p1-d3-164 | Growth (2) | ESPE2014

Characterization of MOD-4023 Glycosylation, a CTP Modified Long Acting GH in Advanced Clinical Stages

Herskovitz Oren , Moschovich Laura , Guy Rachel , Felikman Yana , Fima Eyal

Background: Prolor Biotech, Inc. is a clinical stage public company developing long acting therapeutic proteins utilizing a technology called CTP. The technology involves fusion of the C-terminus peptide of hCG, which is a highly O-glycosylated peptide, to the target protein. Manufacturing process was developed to generate a reproducible highly glycosylated CTP-modified long-acting hGH (MOD-4023), which supports a single weekly injection in GH deficient patients. MOD-...

hrp0082fclb1 | Late Breaking Abstracts | ESPE2014

Top Line Results of Once-Weekly, CTP-Modified Human GH (MOD-4023): Phase 2 Dose Finding Study in Children with GH Deficiency

Zadik Zvi , Rosenfeld Ron , Radziuk Klaudziya , Zelinska Nataliya , Malievsky Oleg , Iotova Violeta , Skorodok Julia , Koren Ronit , Amitzi Leanne , Hart Gili , Herskovitz Oren , Fima Eyal

Objective: GH replacement therapy currently requires daily injections, which may cause poor compliance, inconvenience and distress for patients. CTP-modified hGH (MOD-4023) has been developed for once-weekly administration in GH deficient (GHD) adults and children. Pharmacokinetics (PK), pharmacodynamics, (PD) efficacy and safety analysis of weekly treatment with MOD-4023 in GHD naïve children was performed and compared to daily hGH.Design and metho...