歌禮制藥-B(01672.HK)：治療肥胖症的減重不減肌候選藥物ASC47與司美格魯肽聯合用藥在臨牀前模型中顯示出優於司美格魯肽單藥的減重效果
格隆匯12月18日丨歌禮制藥-B(01672.HK)公吿，董事會宣佈，同類首創治療肥胖症的減重不減肌候選藥物ASC47與司美格魯肽聯合用藥在飲食誘導肥胖(DIO)小鼠模型研究中顯示出令人鼓舞的療效。
ASC47是歌禮自主研發的脂肪靶向、每月一次皮下注射的甲狀腺激素受體β(THRβ)選擇性小分子激動劑。ASC47具有獨特的差異化特性，能夠靶向脂肪，從而在脂肪組織中產生劑量依賴性的高藥物濃度。
在澳大利亞進行的低密度脂蛋白膽固醇(LDL-C)偏高受試者I期單劑量遞增(SAD)研究(NCT06427590)的期中數據顯示，皮下注射ASC47的半衰期為21天。此外，ASC47顯示出了良好的耐受性，當前劑量已遞增至90mg，無嚴重不良事件(SAE)發生，也未發生因不良事件(AE)而導致的停藥。大多數AE為輕度(1級)。沒有報吿胃腸道和心臟AE，沒有報吿肝酶異常(鏈接)。更高劑量的研究仍在進行中。
在此前的臨牀前研究中，常規劑量ASC47(45mg/kg，皮下注射，每兩週一次)單藥顯示出總體重下降24.6%的療效，與司美格魯肽單藥(下降23.1%，30nmol/kg，皮下注射，每日一次)療效相似。常規劑量ASC47使肌肉總量增加5.8%，而司美格魯肽使肌肉總量減少9.3%(鏈接)。
ASC47是一款脂肪靶向、每月一次皮下注射的甲狀腺激素受體β(THRβ)選擇性小分子激動劑。在澳大利亞進行的LDL-C偏高受試者I期單劑量遞增(SAD)研究(NCT06427590)期中數據已公佈。ASC47當前正在澳大利亞進行肥胖症患者臨牀試驗，IIa期研究頂線數據預計將於2025年第二季度公佈。除ASC47外，歌禮還在開發ASC30，該藥已進入治療肥胖症的I期臨牀試驗。ASC30是一種小分子GLP-1R，可每日口服一次或每月皮下注射一次。ASC30每日一次口服片(NCT06680440)和ASC30每月一次皮下注射劑(NCT06679959)當前均在美國開展Ib期用於肥胖症治療的臨牀試驗。頂線數據預計將於2025年第一季度公佈。
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