The ENDO 2022 Annual Congress took place from June 11-14, 2022. During the Congress, stakeholders met to discuss care, treatments, and research within endocrinology. In a news release from global healthcare company Novo Nordisk, the company shared that it had presented data from the Phase 3 REAL 4 clinical trial. This trial evaluated Sogroya (somapacitan) in comparison to Norditropin (somatropin) for children with pediatric growth hormone deficiency (GHD). Altogether, the data showed that Sogroya could offer a more accessible and less time-consuming option for patients with the same efficacy as current treatment options.
Sogroya: An Overview
To begin, let’s unpack what Sogroya is. Developed by Novo Nordisk, Sogroya is a human growth hormone analog which replaces endogenous growth hormone. It is administered once a week via subcutaneous injection. Currently, Sogroya is not approved for use in pediatric patients with GHD and is only available for adult patients. Learn more about Sogroya here.
Researchers evaluated Sogroya in the Phase 3 REAL 4 trial. The goal of the trial was to understand the safety, efficacy, and tolerability of Sogroya in pediatric patients. During the trial, researchers compared Sogroya to Norditropin, which is currently approved for children with growth disorders. However, Norditropin can be invasive and time-consuming; patients must often undergo daily injections over a long period of time to stimulate their growth. Altogether, 200 prepubescent patients with no prior treatment enrolled in the trial. Patienrs received either 0.16mg/kg Sogroya or 0.034mg/kg Norditropin. The researchers found that both treatments had similar outcomes, meaning that Sogroya was not inferior to Norditropin. Therefore, it could represent a future therapeutic option.
Additionally, Sogroya was safe and relatively well-tolerated. While some side effects did occur, many were mild. These included nausea and vomiting, fever, headaches, a common cold, bronchitis, and pain in the extremities.
What is Pediatric Growth Hormone Deficiency (GHD)?
Pediatric growth hormone deficiency (GHD) is a rare childhood disorder in which the body fails to produce enough growth hormone (GH). Normally, the pituitary gland releases growth hormone into the blood, which increases other hormones and proteins. This growth hormone also plays a role in our growth and height. But when the body does not produce enough growth hormone, people experience an abnormally short stature. Pediatric GHD can result from genetic mutations or brain defects, brain trauma, infection, radiation therapy, or unknown causes. Typically, children with pediatric GHD are often normal-sized at birth, although other symptoms appear later. These can include:
- Stunted growth and a short stature
- A “chubby” build
- Hypoglycemia (in newborns)
- A prominent forehead
- Slowed tooth eruption
- High-pitched voice
- Poor nail growth
- Fine hair