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LG Life Sciences, Ltd.(LGLS) together with Biopartners GmbH today presented positive phase 3, placebo controlled six month efficacy and safety data in adults with growth hormone deficiency (GHD) for LB03002, a once-a-week, sustained release recombinant human growth hormone, at the 91st annual meeting of the Endocrine Society being held in Washington (ENDO 09).
Involving close to 150 adult patients with GHD in Europe and the US, the phase III trial demonstrated statistically significant clinical superiority of LB03002 over placebo, with a low incidence of adverse events. Compared to placebo, LB03002 demonstrated superiority in the reduction of fat mass, with positive impact on reduction of trunk fat mass and increase in lean body mass. LB03002 was also effective in producing notable increases in serum IGF-1 levels in adult patients with GHD.
“We are really pleased with this important data which demonstrates the potential of LB03002 in providing better treatment options for the GHD patients. We believe the once-a-week treatment regimen will be very attractive to the patients, leading to better adherence to long-term therapy, and ultimately, more successful treatment outcome.” said Hyi-Jeong Ji, vice president of LGLS, hGH Development Team. LG Life Sciences, together with BioPartners, is currently analyzing data from an open-label extension of this phase 3 study to evaluate long term safety and efficacy.
LB03002 was originally developed utilizing LGLS’ proprietary formulation technology, BiohydrixTM. LB03002 is currently being co-developed by LGLS and Biopartners for pediatric and adult growth hormone deficiency under a license agreement in which LGLS granted rights to Biopartners in Europe, Australia, New-Zealand and select Asian and African countries. LGLS retains rights in the rest of the world including North and South America, and most Asian countries including Korea, Japan, and China.
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