Genexin and Handok have announced the intermediate results of phase 2 clinical trials for GX-H9 at the International Meeting of Pediatric Endocrinology (IMPE).
GX-H9 is a new persistent growth hormone, which is being co-developed by Genexin 제넥신 and Handok 한독 using genetically engineered antibody fusion technology owned by Genexin. It is a next-generation drug that can be administered once a week or once every two weeks, unlike the existing daily administered growth hormone products.
The interim results of phase 2 clinical trials for pediatric subjects showed the comparison in annual height growth in the six-month term for 43 subjects 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 10.8 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 12.3 centimeters per year.
Also, the growth rate of GX-H9 to subject groups administered with 0.8 milligrams/kilogram for every week was about 11.7 centimeter per year, while those administered with 1.2 milligrams/ kilogram was about 13.1 centimeters per year.
“No serious adverse events related to GX-H9 emerged in the clinical trials conducted until now,” said a company official. “The annual height growth rate was similar at six months compared with the three-month annual height growth rate announced in April.”
In particular, the trial confirmed that it is possible to induce a height growth of 10 centimeters or more per year to that of the daily administered reference drug while being administered once every two weeks with no serious adverse effects, he added.
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