A new sustained-release human growth hormone has been shown be just as safe and effective as existing daily therapies in children with growth hormone deficiency (GHD).
The key phase II/III trial data was presented to the Annual Meeting of the European Society for Paediatric Endocrinology in Istanbul by biopharmaceutical company Biopartners.
The once-a-week, sustained-release recombinant human growth hormone LB03002 demonstrated safety and efficacy profiles comparable with existing, daily human growth hormone products in children with GHD.
Biopartners is well advanced in its pivotal phase III sustained-release recombinant human growth hormone trials in children and adults with GHD and is on track to submit a marketing authorisation application to the European Medicines Agency (EMEA) next year.
Jean-Noël Treilles, the company’s chief executive, said: “We are delighted with this news, which we believe confirms our lead in this important therapeutic area where a new treatment modality has been long awaited.
“With this three-year study we have set another important milestone on our way to enabling a regulatory submission to EMEA in 2009, confident that the safety and efficacy profile of the sustained release formulation will be conducive.”
LB03002 was originally developed by LGLS, which granted Biopartners a licence to further develop and market it in Europe, Australia, New-Zealand and selected Asian and African countries.
Copyright PA Business 2008