歌禮制藥-B(01672.HK)與Galmed拓展NASH管線開展Aramchol與ASC41聯合用藥研究
格隆匯 9 月 9日丨歌禮制藥-B(01672.HK)發佈公告，公司全資附屬公司甘萊製藥有限公司與Galmed Pharmaceuticals Ltd.(Galmed，納斯達克交易代碼：GLMD，一家處於臨牀階段藥物開發的生物製藥公司，專注於肝臟、代謝及炎症疾病)達成合作研究，該協議旨在就非酒精性脂肪性肝炎(NASH)治療採用ASC41(甲狀腺激素β受體激動劑)及Aramchol(SCD 1抑制劑)進行聯合治療。
ASC41為一款口服甲狀腺激素β(THR-beta)受體激動劑，其NASH適應症研究性新藥申請(IND)已於近期獲中國國家藥品監督管理局(NMPA)批准。對低密度脂蛋白膽固醇>110 mg/dL的健康志願者的I期臨牀研究的安全性、藥代動力學及初步療效(低密度脂蛋白膽固醇)的頂線數據有望於2020年底前獲得。ASC41可以選擇性地激活THR-beta，從而以直接和間接的方式改善脂肪變性╱脂毒性、炎症、氣球樣變和纖維化。在兩個NASH動物模型中，在劑量為1/10的Resmetirom (MGL-3196，另一種目前處於III期臨牀試驗的甲狀腺激素β受體激動劑)的條件下，ASC41對肝脂肪變性、炎症及纖維化具有相同程度的改善。
Aramchol為一款新型合成小分子，是由膽酸和花生酸通過穩定的酰胺基團連接而成的共軛物。Aramchol通過抑制肝細胞及肝星狀細胞(HSC)中的SCD 1的表達來發揮其抗脂肪變性及抗纖維化的效果。在肝細胞中，SCD 1的減少會導致 AMPK、FA氧化和谷胱甘肽比升高。在HSC中，抑制SCD 1會導致PPAR γ的特異性上調，從而阻止膠原蛋白的形成。在NASH II期臨牀試驗中，Aramchol能顯著減少肝脂肪，改善肝組織學指標(包括氣球樣變及纖維化、肝生物化及血糖指標)，且具有良好的安全性及耐受性。Aramchol目前正在進行一項治療NASH及纖維化的III期註冊研究(ARMOR)，並已獲美國食品藥品監督管理局授予治療NASH 的“快速通道”資格。
公司認為，由於NASH治療存在巨大醫療需求且藥物市場潛力巨大，採用兩種候選藥物進行聯合治療可對NASH治療產生協同效應。
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