Genexine and Handok have announced the intermediate results of phase 2 clinical trials for GX-H9, a persistent growth hormone, at ENDO 2018, the Endocrine Society's annual meeting.
GX-H9 is a new persistent growth hormone, which is being co-developed by Genexine and Handok using genetically engineered antibody fusion technology owned by Genexine. It is a next-generation drug that can be administered once a week or twice a month, unlike the existing daily injected growth hormone products.
The interim results of phase 2 clinical trials for pediatric subjects showed the comparison of annual height growth in the six-month term when administered with either GX-H9 or Genotropin, a reference drug developed by OPKO Health.
Researchers found the annual height growth rate of the control group treated with Genotropin was about 11.24 centimeters per year, whereas the group administration with GX-H9 at 2.4 milligrams/kilogram for every two weeks showed a growth rate of about 11.86 centimeters per year.
Also, the growth rate of GX-H9 to subject groups administered with 0.8 milligrams/kilogram for every week was about 11.5 centimeter per year, while those administered with 1.2 milligrams/ kilogram was about 11.54 centimeters per year.
Based on these clinical results, the company expects that GX-H9 will significantly improve the convenience of medication as it showed similar results as Genotropin. Following the phase 2 clinical trials in Europe and Korea, the company plans to conduct phase 3 clinical trials in the U.S. this year.
“Daily administered growth hormone sales reached 4 trillion won ($3.74 billion) as of 2017,” the company said in a statement. “We expect that the growth hormone market will sharply grow once we launch our next generation product.”