OPKO Health and Pfizer have reported positive results from the Phase III clinical trial of somatrogon compared to Genotropin (somatropin) in children suffering from growth hormone deficiency (GHD).
Somatrogon is an investigational molecule entity. It comprises the natural growth hormone sequence, a C-terminal peptide (CTP) copy from the human chorionic hCG’s beta chain at the N-terminus, and two copies at the C-terminus.
OPKO Health and Pfizer partnered in 2014 to develop and commercialise somatrogon to treat GHD.
Genotropin is Pfizer’s prescription medicine approved in the US to treat GHD in adults.
The randomised, open-label, active-controlled Phase III trial evaluated once-weekly somatrogon compared to daily Genotropin in 224 pre-pubertal treatment-naïve paediatric patients.
The trial was conducted in more than 20 countries and measured height velocity at 12 months as the primary endpoint. Secondary endpoints included safety, pharmacodynamics and change in height standard deviation at six and 12 months.
According to top-line data, somatrogon demonstrated non-inferiority to Genotropin on height velocity at 12 months. The height velocity difference between the somatrogon and Genotropin groups was 0.33.
Patients treated with somatrogon also showed a higher change in height standard deviation scores at six and 12 months versus those who received Genotropin.
The new molecule also led to a comparatively higher change in height velocity at six months.
Safety analysis found somatrogon to be generally well tolerated, with similar types, numbers and severity of the adverse events to those observed in somatropin group.
OPKO Health chairman and CEO Phillip Frost said: “Somatrogon is a new molecular entity incorporating OPKO’s proprietary long-acting technology.
“We believe somatrogon represents a significant advance in the treatment of children with GHD compared to the current standard of one injection per day that could enhance a patient’s adherence to treatment and quality of life.”
OPKO is carrying out the molecule’s clinical programme, while Pfizer is responsible for registration and commercialisation.