OPKO Health, Inc., a multinational biopharmaceutical and diagnostics company, has completed enrollment in the single pivotal phase 3 trial of its long acting human growth hormone (hGH-CTP) in growth hormone deficient (GHD) adults.
The trial is designed to evaluate the safety and efficacy of hGH-CTP with a primary endpoint of superiority compared to placebo in decreasing fat mass in adults with GHD. The trial is a randomized, double-blind, placebo-controlled, multi-center, global study in adults with GHD. The study is divided into two treatment periods: a 26-week, double-blind, placebo-controlled period, followed by a 26-week, open-label extension.
The study is expected to end toward the second half of 2016; regulatory submission will follow study completion.
OPKO has a world-wide collaboration agreement with Pfizer, Inc. for the development and commercialisation of hGH-CTP.
hGH-CTP is a novel, long-acting recombinant human growth hormone analog being developed by OPKO for the treatment of children with growth failure due to inadequate endogenous growth hormone secretion, and adults with growth hormone deficiency (GHD) of either childhood or adult-onset etiology. hGH-CTP is intended to reduce the burden of daily injection therapy.
OPKO's proprietary technology enables elongation of a therapeutic protein's half-life without the use of polymers, encapsulation techniques, or nanoparticles. This technology is based on a natural peptide, the C-terminal peptide (CTP) of the beta chain of human chorionic gonadotropin (hCG). hGH-CTP has been granted orphan drug designation in the US and Europe for both adults and children with growth hormone deficiency.