Novo Nordisk's Once-Weekly Somapacitan Shows Superior Efficacy Over Daily Norditropin in Pediatric Growth Hormone Deficiency
Sep 23, 2019 16:32
CST Updated
16:32
Novo Nordisk
Insulin Developer and Manufacturer
September 23, 2019/BioValleyBIOON/-- Danish pharmaceutical giant Novo Nordisk recently unveiled new data from the Phase II clinical study REAL-3, which evaluated the efficacy and safety of once-weekly somapacitan, a growth hormone derivative, compared with once-daily Norditropin (somatropin, a growth hormone), at the 58th Annual Meeting of the European Society for Paediatric Endocrinology (ESPE) held in Vienna, Austria.
This study was a multinational, randomized, parallel-group, active-controlled trial conducted in 59 prepubertal children with growth hormone deficiency (GHD) who were previously untreated with growth hormone (i.e., treatment-naïve), to evaluate the efficacy and safety of once-weekly somapacitan multi-dose regimens compared with once-daily Norditropin over 26 and 52 weeks. Patients were randomized to receive somapacitan (0.04, 0.08, or 0.16 mg/kg/week) or Norditropin (0.034 mg/kg/day). The study includes an ongoing extension phase lasting up to 312 weeks.
The one-year results presented at this conference support the previously reported six-month data. New one-year data show that the mean annualized height velocity (HV, cm/year), expressed as standard deviation (SD), for somapacitan 0.16 mg/kg/week was statistically significantly higher than that of once-daily Norditropin. The mean annualized height velocities for the three dose levels of somapacitan were 7.8 cm, 9.7 cm, and 11.5 cm, respectively, compared to 10.0 cm for once-daily Norditropin. In this study, somapacitan was well tolerated at all doses, with no clinically relevant safety or local tolerability issues identified. The safety profile of Norditropin was consistent with its known safety profile.
Ludovic Helfgott, Executive Vice President at Novo Nordisk, stated: “At Novo Nordisk, we are proud to be developing once-weekly somapacitan for patients with growth hormone deficiency (GHD), with the aim of reducing their treatment burden and ultimately improving their lives. The results presented at the conference support the Phase III pediatric study of somapacitan. Based on clinical trial results in adult patients with GHD, we have recently submitted regulatory applications for somapacitan for the treatment of adults with GHD in Europe and the United States.”
Somapacitan is a long-acting analog of human growth hormone that utilizes protein technology applied for nearly 20 years to extend the half-lives of insulin and GLP-1. It is currently under development for the treatment of growth hormone deficiency. Somapacitan is derived from natural human growth hormone, modified to enhance its binding to the plasma protein albumin, thereby enabling once-weekly administration.
Growth hormone is a protein produced by the pituitary gland that regulates growth and metabolism. Growth hormone deficiency (GHD) in children is a rare condition characterized by insufficient circulating growth hormone to support normal growth. Affected children experience slowed or halted growth and metabolic disturbances starting from age 2–3 years. The impact of GHD is substantial, affecting multiple aspects of daily life in children at this developmental stage, including physical health, as well as social and emotional well-being. If treatment is initiated early, affected children can achieve normal adult height.
Currently available growth hormone medications require daily subcutaneous injections, which can impose a significant treatment burden on patients and their caregivers. The fatigue associated with years of daily injections may negatively impact treatment adherence, leading to poorer therapeutic outcomes. Non-adherence to growth hormone therapy has been shown to adversely affect height outcomes in children with growth hormone deficiency (GHD). Once-weekly long-acting formulations would represent a major advance for these patients and their families, enabling them to lead lives with fewer disruptions. (Bioon.com)