OPKO Health, Inc. announced the presentation of two posters at the 97th Annual Meeting of the Endocrine Society (ENDO 2015) on March 5th, 2015 in San Diego, California, that included twelve months data from OPKO’s advanced phase 2 trial for its long acting human growth hormone hGH-CTP in growth hormone deficient pediatric subjects.
The presented data included results for 45 patients completing twelve months of treatments. This phase 2 study is a dose finding study administering three different doses of once weekly hGH-CTP comparing to a fixed dose of daily Genotropin® to growth hormone deficient children. The twelve months data confirm comparable response of hGH-CTP to daily Genotropin®, as reflected by the similar twelve months IGF-1SDS profile, annual height velocity (HV), HV SDS and safety profile. The data affirm the selection of an optimal dose that will potentially demonstrate non-inferiority compared to daily hGH in the upcoming phase 3 study in pediatric GHD patients.
OPKO poster presentations included the following:
THR-148: “Top Line Results of 12 Months of Once-Weekly Administration of CTP-Modified Human Growth Hormone (MOD-4023): Phase 2 Dose Finding Study in Children with Growth Hormone Deficiency (GHD)”
THR-151: “Twelve Months Pharmacokinetics and Pharmacodynamics Profile of Once-Weekly, CTP-Modified Human Growth Hormone (MOD-4023): Phase 2 Study in Children with Growth Hormone Deficiency”