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歌禮制藥-B(01672.HK):脂肪酸合成酶抑制劑ASC40治療中、重度痤瘡II期臨牀試驗完成首例患者給藥
格隆匯 01-13 17:02

格隆匯1月13日丨歌禮制藥-B(01672.HK)發佈公吿,公司已完成ASC40治療中、重度痤瘡的II期臨牀試驗首例患者給藥。ASC40是一款選擇性的脂肪酸合成酶(FASN)口服小分子抑制劑,脂肪酸合成酶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,而脂肪酸合成酶抑制劑ASC40可抑制皮脂分泌。

該II期研究是一項在中國開展的隨機、雙盲、安慰劑對照、多中心臨牀試驗,旨在評估ASC40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三個活性藥物組和一個安慰劑對照組,並接受一日一次口服ASC40 (25 mg、50 mg、75 mg)或安慰劑治療,為期12周。主要研究指標包括治療第12周總皮損計數相對基線的百分比變化和╱或治療第12周研究者總體靜態評分(IGA)相對基線降低≥2分的患者比例。

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。 

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