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Genexine Releases Positive Interim Phase 2 Clinical Data from PGHD Trial with long-acting growth hormone, GX-H9 at ENDO 2017
Genexine Inc. (KOSDAQ: 095700) and Handok Inc. (KOSPI: 002390), co-developing next-generation, long-acting recombinant human growth hormone (rhGH) consisting with Genexine’s proprietary hybrid Fc (hyFc) platform technology for pediatric and adult growth hormone deficiency (GHD) patients called GX-H9, today presented positive interim results from the ongoing phase 2 clinical trials of GX-H9 in pediatric growth hormone deficiency and full data from adult growth hormone deficiency (GHD) at the 99th Annual Meeting of the Endocrine Society for Pediatric Endocrinology (ENDO) on April 1st, 2017.
In multi-national, open label, randomized phase 2 pediatric growth hormone deficiency (GHD) trial, GX-H9 demonstrated annualized height velocities comparable to that of active comparator, daily recombinant human growth hormone (rhGH) at 3 months. This interim analysis was conducted with data obtained from 24 patients, which represents approximately 50% of the total enrollment in the trial completing three months out of the total six months of treatment. Key conclusions from the interim analysis include:
- mean annualized height velocities at 3 months were 10.7 cm and 15.3 cm for the two weekly doses of 0.8 mg/kg and 1.2mg/kg, respectively;
- twice-monthly dosing group receiving 2.4mg/kg, the mean annualized height velocity was 12.4 cm;
- mean annualized height velocities from three doses with weekly and twice monthly frequencies were comparable to active comparator, daily injections of Genotropin® with the mean annualized height velocity of 12.7cm;
- a dose-proportional increase in IGF-1 levels was observed following dosing of the three GX-H9 hormone doses in PGHD trial;
both in pediatric and adult growth hormone deficiency (GHD) trials, GX-H9 was safe and well tolerated and the adverse events were comparable to those found in daily hGH treatment and dose-dependent PK/PD profiles were observed.
US FDA Office of Orphan Products Development (OOPD) has granted GX-H9 as an orphan drug designation for the treatment of growth hormone deficiency on November 9th 2016. These GX-H9 trials have been funded partially by Korean Drug Development Fund (KDDF). Genexine and Handok are expecting full six-month efficacy results from PGHD trial in the 2ndhalf of 2017.
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