歌禮制藥-B(01672.HK)：甘萊每日一次ASC41片治療經肝穿活檢證實的非酒精性脂肪性肝炎患者52周II期臨牀試驗取得積極期中結果
格隆匯1月2日丨歌禮制藥-B(01672.HK)發佈公吿，公司全資附屬公司甘萊製藥有限公司的候選藥物甲狀腺激素受體β(THRβ)激動劑ASC41片用於治療經肝穿活檢證實的非酒精性脂肪性肝炎(NASH)患者的52周II期臨牀試驗取得積極期中結果。ASC41具有肝臟靶向性和高度的THRβ選擇性。一日服用一次的ASC41片劑由歌禮專有製劑技術開發。ASC41片劑製劑專利已在美國獲得授權。
該項隨機、雙盲、安慰劑對照及多中心的II期臨牀試驗(ClinicalTrials.gov : NCT05462353)正在中國開展，預計入組約180名經肝穿活檢證實的NASH患者，以1:1:1的比例隨機分配進入兩個ASC41片治療隊列(2毫克或4毫克，一日一次)和一個安慰劑對照隊列，治療52周並隨訪4周。預設的期中分析在42名入組患者完成為期12周的ASC41片或安慰劑治療後進行。
經磁共振成像質子密度脂肪分數(MRI-PDFF)評估，服用ASC41片的患者肝臟脂肪含量降低與服用安慰劑的患者相比具有統計學顯著性差異。在服用ASC41片的患者中，高達93.3%的患者肝臟脂肪含量較基線相對降低30%及以上，肝臟脂肪含量降低30%及以上與患者實現NASH組織學改善高度相關，尤其是對THRβ激動劑治療的患者而言。
該項隨機、雙盲、安慰劑對照及多中心的II期臨牀試驗旨在評估ASC41片治療經肝穿活檢證實的NASH患者的療效和安全性。入組包括經MRI-PDFF評估基線肝臟脂肪含量為7.5%及以上的，以及肝臟纖維化為F2和F3的患者。該研究允許入組至多15%的肝臟纖維化為F1的患者。約180名患者將以1:1:1的比例隨機分配進入兩個治療隊列和一個安慰劑對照隊列，並接受一日一次口服ASC41片(2毫克或4毫克)或安慰劑，治療52周，並隨訪4周。在基線和52周治療結束時將進行兩次肝穿活檢。在基線、第12周和第52周將進行MRI-PDFF評估。預設的期中分析將在約45名入組患者完成12周的ASC41片或安慰劑治療後進行。
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