hrp0086rfc8.3 | Growth: Clinical | ESPE2016

Batch-to-Batch Consistency of a Highly O-Glycosylated Long-Acting Human Growth Hormone (MOD-4023)

Moschcovich Laura , Guy Rachel , Felikman Yana , Zakar Miri , Hershkovitz Oren

Background: OPKO Biologics is a clinical-stage public company developing long-acting therapeutic proteins utilizing CTP technology. The technology involves fusion of the C-terminal peptide of human chorionic gonadotropin (hCG), which is highly O-glycosylated, to the target protein. CTP enabled the production of a long-acting human growth hormone (hGH) (MOD-4023), which supports a single weekly injection in growth hormone-deficient patients. MOD-4023 is manufactured as a non-vi...

hrp0086p1-p615 | Growth P1 | ESPE2016

Immunogenicity Results of Once-Weekly Administration of CTP-Modified Human Growth Hormone (MOD-4023): A Phase 2 Study in Children with Growth Hormone Deficiency

Mendelson Michal Jaron , Bar-Ilan Ahuva , Hershkovitz Oren , Hart Gili

Background: CTP-modified hGH (MOD-4023) has been developed for once weekly administration in GH deficient (GHD) adults and children. Immunogenicity samples of once-weekly s.c. administration of MOD-4023 were detected for the presence of binding and neutralizing anti-MOD-4023 Ab’s in pediatric Phase 2 study.Objective and hypotheses: During the first year of the study, 53 pre-pubertal GHD children were treated with once-weekly s.c. injections of one o...

hrp0084fc7.5 | Growth-promoting therapies | ESPE2015

12-Month Safety and Efficacy of a Weekly Long-Acting GH (MOD-4023) Compared to Daily Recombinant Human GH Therapy in Pre-Pubertal GH-Deficient Children; Phase 2 Study: Study CP-4-004 Summary

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

Objective and hypotheses: To compare the PK/PD, safety, efficacy, and tolerability of three doses of once-weekly MOD-4023 to that of a daily recombinant human GH (rhGH) formulation in pre-pubertal children with growth failure due to GH deficiency (GHD).Method: The randomised, controlled phase 2 study was conducted in 53 pre-pubertal, hGH-naïve GHD children randomised to receive one of three MOD-4023 doses as a once-weekly s.c. injection (0.25, 0.48,...