Genexine said Friday that it has presented the phase 2 clinical trial results for GX-H9, a pediatric growth hormone deficiency (PGHD) treatment, at the 57th European Society for Pediatric Endocrinology (ESPE) in Greece.
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 clinical study, conducted at 27 endocrinology centers in 10 countries in Europe and Korea, aimed to compare the height growth between the company’s GX-H9 formulation against Genotropin on 50 patients for 12 months.
The research showed that the annual growth rate of the control group treated with Genotropin was about 9.14 cm/year, while the growth rate of GX-H9 to subject groups administered with 0.8 mg/kg for every week was about 10.5 cm/year and those administered with 1.2 mg/kg was about 11.76 cm/year.
Also, the group that received 2.4 mg/kg of GX-H9 every two weeks showed a growth spurt of 11.03 cm/year showing superior results when compared to the control group.
The company also saw no significant slowdown of growth rate after 12 months of GX-H9 or Genotropin treatment when compared with the initial report published after six months.
GX-H9 showed no serious adverse effects and showed similar long-term safety profiles to that of Genotropin.
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