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KDDF-201308-07 Conduct and Completion of a Global Clinical Phase I Trial of a Next-Generation Human Growth Hormone Product(Metabolic Disorders, ) [2016-01-12]

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

Development and Market Objectives

The next generation recombinant human growth hormone (GX-H9) project, which was funded by KDDF, was approved to conduct Clinical Phase I study in Europe. Our goal is to conduct and complete Phase 1 study in EU and carry out monkey PK/PD study and hFcRn transgenic mice PK study to create higher value to the project.

Unmet Medical Need & Target Patients

The global market for human growth hormone is continuously growing at an annual growth rate of 4.6% and with a sales figure of 3 billion US dollars in 2012. The primary target patients are those who suffer from growth hormone deficiencies (both adults and children) and indication is expected to expand to growth failures due to chronic renal insufficiencies, GSA, Prader-Willi Syndrome, Turner’s Syndrome, Cachexia AIDS-related, Noonan Syndrome, ISS, Short Stature Homeobox containing gene deficiency, and Short Bowel Syndrome. Currently, 1st generation recombinant human growth hormone products have poor compliance due to daily injection. Many rhGH products is redeveloped by combining with medical devices to improve compliance, but once-daily injection still cause inconvenience and distress for patients. New generation of rhGH products with longer-acting characteristic such as weekly or monthly administration are under development to improve quality of life for patients.


Status

GX-H9 was approved to conduct clinical phase 1 trial in The Netherlands in August 2013. A global CRO is now conducting a Phase I trial for GX-H9 in healthy male volunteers and plans to conduct further clinical trials in adults and children patients with growth hormone deficiencies.


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. 

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
Global Phase 2 study (AGHD) of next generation human growth hormone drug (GX-H9) in EU/KR and Approval of PGHD trial in EU 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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