A study on the Phase 2 clinical trials on the long-acting growth hormone GX-H9, currently under development by Handok and Genexine, published online in the European Journal of Endocrinology, an international SCI journal

  • Date
    2018.07.20 09:25
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On July 4, a study on the Phase 2 clinical trials for GX-H9, a long-acting growth hormone currently being developed by Handok (CEO: Young-Jin Kim) and Genexine (CEO: You Suk Suh), was published online in the European Journal of Endocrinology. The European Journal of Endocrinology is an international SCI journal published by the European Society of Endocrinology.

The long-acting growth hormone GX-H9 is a next-generation biomedicine made using Genexine’s proprietary hyFc technology. Handok and Genexine are currently developing GX-H9, which can be administered to children or adults in the form of a weekly or twice-monthly injection, unlike existing growth hormones that must be administered daily.

The study published in the European Journal of Endocrinology contained the results of the Phase 2 clinical trials for GX-H9. Professor Ku Cheol Ryong of Severance Hospital is the leading author of the study, and Professor Lee Eun Ji, also from Severance Hospital, is the supporting author. In 2017, the clinical trials for GX-H9 attracted much attention when the interim results were presented at ENDO 2017, the largest event for endocrine science and medicine in the United States.

The Phase 2 clinical trials for GX-H9 were conducted from January 2015 to December 2016 on adult patients in 16 hospitals in seven countries, including Korea, Germany, France, Poland, Hungary, Serbia, and Slovakia. The trials were conducted by administering GX-H9 injections to 45 patients with adult growth hormone deficiency (AGHD) over the course of 12 weeks. GX-H9’s safety and drug tolerance levels, as well as its pharmacodynamic and pharmacokinetic analysis results, showed the long-acting growth hormone’s potential as a treatment that can be administered twice a month.

Currently, only growth hormones that must be administered on a daily basis are available in major global markets, generating approximately KRW 4 trillion in sales as of 2017. Once the next-generation weekly or twice-monthly treatments are released, the growth hormone market is expected to grow significantly.

Handok and Genexine are strategic partners and, in June 2012, signed a technology licensing and joint development agreement for the long-acting growth hormone. In 2014, Handok became Genexine’s largest shareholder. In recognition of its technological excellence, the long-acting growth hormone GX-H9 was selected as a project financed by the Korea Drug Development Fund, and in 2016, received the Orphan Drug Designation by the United States Food and Drug Administration (FDA) for the treatment of growth hormone deficiencies. In 2018, Handok and Genexine came into the limelight when the companies presented their interim results after the completion of six months of Phase 2 clinical trials at the 100th Annual Meeting and Expo of the Endocrine Society, the largest endocrinology organization in the world. After completing their Phase 2 clinical trials for adults and children in European countries and in Korea, Handok and Genexine will submit a request to the U.S. FDA for approval to enter Phase 3 clinical trials early next year.