Japanese healthcare firm, JCR Pharmaceuticals, has announced that it has dosed the first paediatric patient as part of its Phase III trial of JR-142, a long-acting growth hormone designed to treat young patients living with a hormone deficiency.
The open-label multicentre trial (jRCT2031240282) is set to involve 54 paediatric patients treated with JR-142, compared with the company’s currently marketed growth hormone therapy Growject.
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The trial will look to verify the non-inferiority of once-daily subcutaneously administered of Growject against a once-weekly administration of JR-142 in children with short stature due to growth hormone deficiency over a 52-week period. The trial endpoints will examine efficacy and safety with growth outcomes serving as the primary measure of success.
Noriyuki Namba, professor for the division of pediatrics and perinatology at Tottori University Faculty of Medicine, and investigator on the study, said: “I am thrilled to see progress in the development of treatments for pediatric patients.
“Growth hormone therapy typically requires daily injections, but JR-142, as a long-acting therapy, offers the possibility of once-weekly dosing. This advancement has the potential to significantly ease the burden on children and their families, improving both convenience and quality of care while maintaining high safety standards.”
The company’s previous offering, Growject, is one of a few growth hormone products derived from the hormone somatropin. Over the past few years competition in the space has started to heat up. Researchers for GlobalData’s Pharmaceutical intelligence centre estimate that sales for Growject peaked in 2024, seeing sales of $124m, with the product forecast to bring in $101m by 2030. Overall the company is estimated to see sales of $285m by the end of 2024, down from sales of $297m in 2023.
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By GlobalDataGlobalData is the parent company of Clinical Trials Arena.
Elsewhere in the market of human growth hormones, Cosciens Biopharma, saw its stock take a fall after it released topline results from the Phase III DETECT trial of its macimorelin growth hormone stimulation test, showing that the study failed to meet the primary endpoint.
