April 25, 2024

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[THE INVESTOR] South Korean drug maker Genexine said Nov. 21 its long-acting human growth hormone GX-H9 has proved its safety and tolerability in patients with pediatric growth hormone deficiency, or GHD, in its latest clinical trials. 

The biotechnology company presented the findings from multinational phase 2 interim data of GX-H9 for both pediatric and adult growth hormone deficiency clinical trials during the 50th Annual Meeting of the Japanese Society for Pediatric Endocrinology in Tokyo on Nov. 19.

“Based on the current results, GX-H9 demonstrated that it was safe and well tolerated in pediatric GHD patients and the adverse events were comparable to those found in daily growth hormone control,” the company said in a press release.

It added that GX-H9 showed the potential for both weekly and bi-monthly treatment regimen.

GX-H9, being co-developed with South Korea’s pharmaceutical firm Handok under a strategic partnership, is a next-generation, long-acting recombinant human growth hormone consisting of Genexine’s proprietary hybrid Fc platform technology for pediatric and adult GHD patients.

On Nov. 9, the US Food and Drug Administration’s division of Orphan Products Development granted GX-H9 an orphan drug designation for the treatment of growth hormone deficiency.

According to Genexine, the full data from AGHD trials will be obtained by end of this year and interim data from PGHD trials will be available in the first half of 2017.

By Park Han-na (hnpark@heraldcorp.com)