According to a story from globenewswire.com, the experimental drug somatrogon, which is being co-developed by Pfizer, Inc. and OPKO Health, Inc., was able to achieve its primary endpoint in a phase 3 clinical trial. The investigational product candidate was being tested as a treatment for growth hormone deficiency in children that had not entered puberty. The endpoint of this study was “non-inferiority” in effectiveness when compared to injections of somatropin (marketed as GENOTROPIN), a currently approved therapy for the same condition.
About Growth Hormone Deficiency (GHD)
Growth hormone deficiency is a medical condition in which the body’s pituitary gland does not release sufficient levels of growth hormone. It is characterized primarily by abnormally short height. Causes of the condition are varied; it may be the result of a genetic abnormality (the genes GH1, BTK, or GHRHR are typically involved), treatment with radiation therapy, injuries, tumors, or infections. However, the cause is unclear in about a third of cases. Symptoms in children include developmental delays, jaundice, small penis size, low hair growth, and low blood sugar. Symptoms in adults include poor bone density, high cholesterol, reduced muscle mass, baldness (in men), heart problems, increased body fat, and issues with fatigue and concentration. Treatment is typically with supplementation of growth hormone via injection, however this treatment can cause unpleasant side effects. To learn more about growth hormone deficiency, click here.
About The Study
In the study, the child patients were divided into two groups. One group received daily treatment with somatropin and the other received weekly treatment with somatrogon for a year long period. Despite the fact that somatrogon was delivered less often, the rate of growth seen in the children were nearly the same. The somatrogon group saw an average growth rate of 10.12 cm and the somatropin group saw a rate of 9.78 cm. The somatrogon group also saw improved results compared to somatropin in secondary endpoints.
About Somatrogon
Somatropin is essentially the standard form of growth hormone supplementation. Somatrogon appears to offer an improvement because it also includes a copy of the C-terminal peptide (CTP), which extends the molecular half-life. This is what allows patients to receive a similar degree of benefit with less frequent dosing. This has the impact of improving patient quality of life and treatment adherence.
