Phase 3 Study of SR Human Growth Hormone for Growth Hormone Deficiency
Biopartners GmbH and LG Life Sciences (LGLS) Ltd. announced positive results from their Phase 3 study of LB03002, a once-a-week, sustained-release (SR) recombinant human growth hormone (hGH) for the treatment of children with growth hormone deficiency (GHD). This 24-month, efficacy and safety study in 167 pediatric 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.