Genexine Inc. (KOSDAQ: 095700), a clinical stage biotechnology company developing innovative biologics focused on orphan diseases and immuno-oncology, presented EU/KR Phase 2 12-month height velocity data of GX-H9 for pediatric growth hormone deficiency (PGHD) at57th European Society for Paediatric Endocrinology (ESPE) in Athene, Greece. GX-H9, being co-developed with HANDOK Inc. under a strategic partnership, is a next-generation long-actingform of recombinant human GH (rhGH) using Genexine’s hybrid Fc (hyFcTM) platform technology which is being developed into both weekly and twice-monthly administration treatments.
This clinical study, conducting at 27 endocrinology centers in 10 countries of Europe and Korea, was designed to compare 12-month effects of weekly and every other week (EOW) administrations of GX-H9 to that of daily Genotropin®(Pfizer). The released data included actual 12-month height velocity results from 50 patients who have been treated for at least 12 months. The annualized height velocity after 12 months of treatment was comparable between all doses of GX-H9 and Genotropin®. Compared to 9.14cm mean annualized height velocity of Genotropin®, two weekly dosing groups of 0.8mg/kg and 1.2mg/kg showed height velocity of 10.50cm and 11.76cm at 12 months, respectively. Furthermore, the EOW dosing group of GX-H9, which received 2.4mg/kg, showed 11.03cm of height velocity.
No significant slowdown of growth rate was observed after 12 months of GX-H9 or Genotropin® treatment compared to annualized height velocity calculated after the first 6months of treatment. No lipoatrophy nor insulin resistance was observed in this study so far, and long-term safety profiles from all treatment groups of GX-H9 were comparable to that of Genotropin®. GX-H9 showed a positive potential for both weekly and twice-monthly treatment regimen.
GX-H9 has been funded by Korean Drug Development Fund (KDDF) since 2015.