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KDDF-201502-11 Global Phase 2 study (AGHD) of next generation human growth hormone drug (GX-H9) in EU/KR and Approval of PGHD trial in EU(Metabolic Disorders, Protein) [2018-02-28]

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Ongoing Project
Section Lead
Generation
Lead
Optimization
Preclinical Phase I Phase II Phase III

Development and Market Objectives

Global clinical development phase 2 for Adult growth hormone deficiency (AGHD) patients and approval of global clinical development phase 2 for pediatric growth hormone deficiency (PGHD) patient.
The market objective is a global license out to major pharmaceutical company in global basis.

Unmet Medical Need & Target Patients

For AGHD, the target population includes patients with pituitary growth hormone secretion disorder with brain tumors, radiation therapy or surgery after a brain hemorrhage, or decreased body profile.

For PGHD, the target population includes pediatric patients with growth hormone secretion disorder or damage in the pituitary, or the growth curve of only 5cm/year or less than 2 SD score of growth in the age group, or patients with low blood sugar, depression and mental immaturity.

When the therapeutic regimen requires more frequent treatment, the possibility of patient compliance tends to be decreased. This may result in growth defect as well as mental stress with reduced quality of life of patients. Some of the sustained release formulation to be used for a thick needle, this formulation may cause pain, injection site pain, this may be a serious problem, especially in children.

Status

KDDF funded Phase 1 study with healthy volunteers has completed, the global clinical trials for AGHD study is completed up to the first and second groups received doses, this trial is approved in 8 countries including South Korean and France. Patient recruitment is underway for the third dose group.

The global trial for PGHD patients is in the process of approval targeting 15 European countries including Russia and Spain.

 

Intellectual Property

The hyFc, a proprietary platform technology developed by Genexine, Inc., is already protected by registered patents in many countries including the United States and Korea.

Competitive Advantages

Development a bi-weekly or monthly administration product by using the hyFc technology

-     The hyFc was developed by hybridizing IgD and IgG4. The IgD portion of hyFc have characteristics of high hinge flexibility and IgG4 have long half-life by Fc region mediated by FcRn. It is also designed to remove ADCC and CDC functions. Long-acting mechanism of GX-H9 is mediated by FcRn recycling which allow bi-weekly or monthly administration.

-     GX-H9 has higher bioavailability when compared to Pegylation or other long-acting technologies. By using the hyFc technology, greater efficacy was shown with lower doses in animal models compared to existing products. Therefore, GX-H9 is expected to show superior efficacy in humans. 

-     The hyFc technology not based on any chemical reaction but on the natural process, which should result in all natural protein metabolites. Therefore, this technology may have distinguished advantage in terms of adverse event during trials.

Contact & Company Overview

Related Project

Related Project
Global Phase 2 study in pediatric patients (PGHD) of next generation human growth hormone drug (GX-H9) and global License out Project view
Conduct and Completion of a Global Clinical Phase I Trial of a Next-Generation Human Growth Hormone Product Project view
Global pre-clinical trial and CTA in the EU for a next generation long-acting human growth hormone Project view
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