歌禮制藥-B(01672.HK):中國國家藥監局批准開展ASC40治療痤瘡患者II期臨試
格隆匯8月9日丨歌禮制藥-B(01672.HK)發佈公吿,中國國家藥監局已批准開展ASC40治療中、重度痤瘡患者的II期臨牀試驗。該II期研究是一項將在中國開展的隨機、雙盲、安慰劑對照、多中心臨牀試驗,旨在評估各劑量組治療中、重度尋常性痤瘡患者的安全性和有效性。計劃入組約180名患者,以1:1:1:1的比例隨機分配進入各隊列組(安慰劑、25 mg、50 mg、75 mg)。
根據披露,痤瘡是世界第八大流行疾病,全球痤瘡患者人數超過6.4億。痤瘡的發病通常與青春期的激素變化有關,在12至25歲的青少年羣體中,受此困擾的比例約佔85%。然而,痤瘡也可以持續至成年或在成年後形成。
目前治療痤瘡的一線藥物包括外用乳膏如維甲酸類、雄激素受體抑制劑、口服異維甲酸和抗生素。Allied Market Research最近發佈的一份報吿顯示:2019年,全球痤瘡藥物市場規模為118.6億美元,預計到2027年將達到133.5億美元。
脂肪酸合成酶(FASN)是調節脂肪酸從頭合成(DNL)途徑中的關鍵酶。皮脂分泌依賴於脂肪酸的從頭合成,在痤瘡形成的過程中,皮脂分泌增多,這一步驟可被 FASN抑制劑ASC40所抑制。痤瘡是ASC40在中國獲批的第三個適應症。其他兩個獲批開展臨牀試驗的適應症是非酒精性脂肪性肝炎和複發性膠質母細胞瘤。
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