Opko Health has completed recruitment of patients in its global phase 3 study of somatrogon (hGH-CTP) in growth hormone deficient children.
Image: Opko Health has completed recruitment of patients in somatrogon’s phase 3 study. Photo: courtesy of Jan Friml / FreeImages.
The company has used multi-dose disposable pen to deliver an investigational long-acting human growth hormone product, somatrogon.
Somatrogon is a new molecular entity, which maintains the natural sequence of growth hormone and can be combined with a C-terminus peptide to expand its half-life.
The study is a randomized, open-label and active-controlled study designed to assess a weekly injection of the investigational long-acting human growth hormone product in more than 30 countries.
Opko Health recruited around 225 treatment-naïve children with growth hormone deficiency (GHD in the study.
The patients were randomized1:1 into two arms, including once-weekly somatrogon and once-daily Genotropin.
According to the company, the primary endpoint of the trial is height velocity at 52 weeks and secondary endpoints are safety and pharmacodynamic endpoints.
In addition, the children completing this study are expected to be recruited in an open-label long-term extension, in which they will secure somatrogon.
Somatrogon produced pharmacodynamic effects similar to daily growth hormone replacement therapy with comparable efficacy and safety in a phase 2 pediatric trial in which growth hormone deficient children were treated with once-weekly injections of somatrogon.
Opko also noted that the long-term safety of somatrogon and absence of neutralizing antibodies is proved the ongoing extension, as 43 of the Phase 2 pediatric patients are in their fourth and fifth year of treatment.
The company secured orphan drug designation in the US and the EU for the treatment of children and adults with GHD.
Opko Health chairman and CEO Dr Phillip Frost said: “We are pleased to have completed enrollment for this study, as the pediatric segment represents approximately 80% of the market for the treatment of GHD.
“We are hopeful that the outcome of this study will support a dosing change from daily to weekly administration and positively impact the quality of life for children with GHD.”
Opko entered into a worldwide collaboration and license agreement with Pfizer to develop and commercialize somatrogon.
As per terms of the deal, Opko has taken responsibility for carrying out the clinical program, while Pfizer will involve in the registration and commercialization of the product.