BAAR, Switzerland / SEOUL, South Korea--(BUSINESS WIRE)--Biopartners GmbH and LG Life Sciences Ltd (LGLS) today presented positive Phase 3 results of 24 months efficacy and safety in children with growth hormone deficiency (GHD) for LB03002, a once-a-week, sustained release recombinant human growth hormone (hGH), at the 50th annual meeting of the European Society of Pediatric Endocrinologists (ESPE 2011) in Glasgow, Scotland.
A Phase 3 trial conducted globally, including Europe and the US, involving 167 paediatric patients with GHD demonstrated that LB03002, using LGLS’ proprietary delivery technology Biohydrix?, maintained expected growth rates for patients continuously treated for 24 months as well as in patients treated for 12 months who were switched from daily therapy. IGF-1 levels continued to increase toward the normal range in both groups during LB03002 treatment, a key marker of efficacy and safety in growth hormone therapy. LB03002 was well tolerated and demonstrated a sustained growth potential without excessive bone maturation.
Commenting on these new results Dr. Conrad Savoy, CEO of Biopartners GmbH said “We are truly excited about the positive impact of this innovative once-a-week recombinant human growth hormone. These positive data further confirm previously presented positive data in children with GHD from a two year comparative trial versus daily growth hormone which was followed by a one year extension.
Dr. Hyi-Jeong Ji, VP of hGH Development at LGLS commented, “Based on this comprehensive set of data in GHD children together with 12 months of efficacy and safety in GHD adults, we believe this novel once-a-week hGH will offer a very attractive treatment modality to endocrinologists and their patients, leading to better adherence to long-term therapy, and ultimately, a more successful treatment outcome.”
LB03002 was originally developed by LGLS who granted Biopartners a license to further develop and market the product in Europe, Australia, New-Zealand and several other countries. LGLS retains rights in the rest of the world including North and South America, and most Asian countries including Korea, Japan, and China. An extension of this paediatric Phase 3 study is currently ongoing in India and Egypt.