Presented EU/KR Phase 2 6-month annualized height velocity data for pediatric growth hormone deficiencies
Genexine Inc. (KOSDAQ: 095700), a clinical stage biotechnology company developing innovative biologics focused on orphan diseases and immuno-oncology, presented EU/KR Phase 2 interim result of GX-H9 for pediatric growth hormone deficiency (GHD) at 10th International Meeting of Pediatric Endocrinology (IMPE) in Washington DC, USA.
GX-H9 is a next-generation, long-acting recombinant human growth hormone (rhGH) based on Genexine’s proprietary hybrid Fc (hyFc) platform technology, for pediatric and adult patients with GHD. GX-H9 is being developed into both weekly and twice-monthly dosing schedules which could dramatically decrease the injection burden of patients.
The interim results included 6-month annualized height velocity data from 43 patients, representing about 90% of the total enrollment, compared to that of the active control, Genotropin®which needs a compliance of daily injection
Compared to 10.8cm mean annualized height velocity of Genotropin®, two weekly dosing groups of 0.8mg/kg and 1.2mg/kg showed height velocity of 11.7cm and 13.1cm at 6 months, respectively. Furthermore, twice-monthly dosing group of GX-H9, which received 2.4mg/kg, showed 12.3cm of height velocity.
This interim results are comparable to that of a long-acting hGH from OPKO Health, Inc. (NYSE: OPK), which has entered into the exclusive license agreement with the global pharmaceuticals company, Pfizer. Under the terms of the agreement, OPKO will receive up to $570 million including $295 million of upfront fee.
Genexine said, “No treatment related serious adverse events occurred, and the interim analysis recorded similar figures with three months data presented in April. GX-H9 has a merit to provide treatment options of both weekly and twice-monthly administration while treatment related adverse events were mild to moderate.”
Moreover, Genexine found this year’s IMPE, which was held in a large-scale including Europe and United States, to be a great opportunity not only to exchange most updated information on pediatric endocrinology, but also to promote efficacy and safety of GX-H9.
GX-H9 has been funded by Korean Drug Development Fund (KDDF) since 2015.
▶ About Genexine:
Genexine, Inc., listed on KOSDAQ (095700) since 2009, is a leading biotherapeutics company focused on orphan diseases and immuno-oncology. Genexine has robust pipelines in clinical and pre-clinical stages based on long-acting Fc fusion technology and therapeutic DNA technology. Three Phase 2 and four Phase 1 clinical trials are currently ongoing in 2017. GX-H9, a long-acting human growth hormone for PGHD, currently in multinational phase 2 trial and phase 2 study for AGHD was completed at the end of last year. Genexine has entered into a manufacturing agreement with a global CMO company, CMC biologics for preparing phase 3 trial. Genexine is located in Pangyo Techno Valley near Seoul.