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On May 12, Novo Nordisk announced the data from the Phase III REAL8 basket trial, which showed that Sogroya (pasireotide), administered once weekly, was comparable to Norditropin (somatropin), administered once daily, in improving the annual growth rate (measured by height velocity HV at 52 weeks) in prepubertal children with Small for Gestational Age (SGA), Noonan Syndrome (NS), and Idiopathic Short Stature (ISS). Additionally, in children with Noonan Syndrome (NS), Sogroya demonstrated superiority over the once-daily growth hormone, and in children with Small for Gestational Age (SGA), Sogroya also showed superiority over the once-daily low-dose growth hormone.
Sogroya is a human growth hormone analog, similar to the current daily growth hormone. Using albumin-binding extension technology, Sogroya attaches to albumin in the blood to help delay its clearance from the body, allowing the growth hormone to function for a longer period. The drug has currently been approved by the FDA for the treatment of children and adults with growth hormone deficiency.REAL8 adopts an innovative basket trial design, investigating the use of weekly Sogroya across four different but related indications (SGA, TS, NS, and ISS) under a single trial protocol. This trial design makes the clinical development process more efficient by accelerating recruitment and integrating resources, with the potential to bring treatment options to patients with these conditions more quickly. This marks the first time such a trial design has been implemented in the field of growth disorders.REAL8 Trial Met Its Primary Endpoint in the First Three Sub-Studies: At 52 Weeks, Weekly Sogroya Was Non-Inferior to Daily Growth Hormone Therapy in the Following Three Indications:- In children born small for gestational age (SGA), Sogroya demonstrated a higher mean annual growth rate (11.0 cm/year vs 9.4 cm/year) compared to daily low-dose (0.035 mg/kg) growth hormone, and a meanThe annual growth rate was comparable (11.0 cm/year vs 11.1 cm/year).
- In children with Noonan Syndrome (NS), Sogroya compared to daily growth hormone, on averageAnnual growth rate was better (10.4 cm/year vs 9.2 cm/year).
- In children with idiopathic short stature (ISS), Sogroya compared to daily growth hormone, on averageThe annual growth rate is equivalent (10.5 cm/year vs 10.5 cm/year).
REAL8 Study Shows Sogroya Well-Tolerated, No Safety or Tolerability Issues Found Compared to Once-Daily Growth Hormone. Insulin-Like Growth Factor 1 (IGF-1) Levels in Patients Treated with Sogroya Were Similar to Those Treated with Once-Daily Growth Hormone. Results from the Turner Syndrome (TS) Portion of the REAL8 Study Will Be Announced Later This Year.Non-adherence to growth hormone therapy is a common issue among patients, putting treatment outcomes at risk. Daily injections can become a burden for children and their caregivers due to discomfort or pain at the injection site, inconvenience, and the impact on daily life, leading to non-adherence. A study showed that patients who missed daily injections had a height difference of 6.1 cm over three years compared to those who were adherent.Novo Nordisk’s Executive Vice President of Development, Martin Lange, stated: "Treatment adherence is a challenge in improving outcomes for children with growth delays. Consider this: if a child misses just one day of treatment per week, that adds up to 52 missed doses in a year. Over a seven-year treatment window, it equates to missing an entire year of treatment, which can have significant downstream effects on their health. We are committed to providing growth hormone therapies with dosing time flexibility and the ability to address missed doses, better meeting the needs of children with growth delays. These results from the REAL8 study represent an important step forward in fulfilling that commitment."In April, based on data from the REAL8 and REAL9 studies, Novo Nordisk submitted these three indications (SGA, NS, and ISS) to regulatory authorities in the EU and the US for review.Scan the WeChat QR code to add.Medicine Space-TimeEditorPlease indicate: Name + Research Direction!
