Date: 2011-09-27
Type of information:
phase: 3
Announcement: results
Company: Biopartners (Switzerland) LG Life Sciences (Korea)
Product: LB03002 (once-a-week, sustained release recombinant human growth hormone (hGH))
Action mechanism:
Disease: growth hormone deficiency
Therapeutic area: Hormonal diseases - Endocrine diseases
Country: Europe USA
Trial details:
Latest
news: Biopartners GmbH and LG Life Sciences Ltd (LGLS) have 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 for Paediatric Endocrinology (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.
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.
