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聖諾醫藥-B(02257.HK)啟動RNAi治療藥物STP705進行用於醫學美容治療的成人腹部減脂整形I期臨牀研究
格隆匯 05-30 12:17

格隆匯5月30日丨中國蘇州生物醫藥產業園— 聖諾醫藥(Sirnaomics Ltd.)("Sirnaomics",股份代號:2257.HK)宣佈啟動一項該公司siRNA(小干擾RNA)的I期臨牀試驗,應用候選藥物STP705對成人實施腹部整形以減少頦下脂肪。這項研究是Sirnaomics首次嘗試將RNAi治療產品應用於醫學美容治療。

2021年全球非侵入性減少脂肪的市場規模為11億美元,預計從2022年到2030年的複合年增長率(CAGR)為16.1%,最高預計為40億美元(Grand View Research)。非侵入性減少脂肪是一種通過使用冷凍脂肪分解、射頻和鐳射脂肪分解等方法來減少或消除身體特定部位頑固脂肪袋的流程。在這些手術中用於永久消除脂肪細胞的非侵入性設備已經獲得美國食品藥品監督管理局(FDA)批准,事因該手術的效率和安全性已獲得驗證,且結果亦被證實顯示出明顯的療效。然而,目前由設備為主導的治療效果較一般、且需要宂長療程。而Sirnaomics將初步專注於使用STP705進行局部皮下給藥的頦下減脂。

這項劑量範圍、隨機、雙盲、載體對照研究將招募10名患者以評估STP705的安全性和耐受性,STP705將通過皮下注射給藥。其主要終點是評估注射舒適性、表徵局部和全身安全性,以評估STP705皮下劑量的組織學變化,並比較三種不同濃度STP705的安全性和耐受性,以選擇未來研究的劑量。

"頦下充盈是一種對節食和運動有抵抗力的常見症狀,並且受到包括衰老和遺傳學在內的多種因素的影響。"Sirnaomics執行董事兼首席醫務官MichaelMolyneaux博士説,"我們通過這項研究擴展STP705應用範圍,目的是研究這種療法在頦下整形患者中的安全性和有效性。我們希望利用本研究的資訊,拓展到頦下減脂治療和非侵入性脂肪重塑的其他領域。這項I期研究將作為STP705在醫學美容學類別中未來研究的藍圖。"

Sirnaomics創始人、董事會主席、執行董事、總裁兼首席執行官陸陽博士表示:"目前用於非侵入性減脂的設備和程式具有温和的治療效果,需要多次且偶爾具有挑戰性的治療過程,這對患者來説成本高昂,並且不常達到預期的效果。基於我們先前臨牀研究的發現和一系列動物模型的臨牀前評估,我們決定通過這項I期研究將STP705治療應用擴展到醫學美容中。"

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