青蒿素衍生物红斑狼疮候选新药进入II期临床

2019-07-15 黄辛 中国科学报

中国科学院上海药物研究所左建平课题组和李英课题组,通过对天然产物青蒿素进行结构优化,获得了具有更强免疫抑制活性的水溶性青蒿素衍生物马来酸蒿乙醚胺,并获得国家药品监督管理局临床试验批件。最近,通过上海交通大学医学院附属仁济医院的伦理审查,该药II期临床试验在该院风湿免疫科开展。据悉,这种新型青蒿素衍生物的免疫抑制活性发现及应用,已获得国内外两项专利授权,拥有完全的自主知识产权。系统性红斑狼疮是最复杂

中国科学院上海药物研究所左建平课题组和李英课题组,通过对天然产物青蒿素进行结构优化,获得了具有更强免疫抑制活性的水溶性青蒿素衍生物马来酸蒿乙醚胺,并获得国家药品监督管理临床试验批件。最近,通过上海交通大学医学院附属仁济医院的伦理审查,该药II期临床试验在该院风湿免疫科开展。

据悉,这种新型青蒿素衍生物的免疫抑制活性发现及应用,已获得国内外两项专利授权,拥有完全的自主知识产权。

系统性红斑狼疮是最复杂、最严重的自身免疫性疾病,由于发病机制不清和疾病的异质性,使得治疗药物的研发成为国际药学界公认的最具挑战性的研究领域之一。

马来酸蒿乙醚胺是服用方便的新型小分子药物,疗效作用机理清楚。作为治疗系统性红斑狼疮的化学I类候选新药,现已完成I期临床研究,与目前广泛使用的治疗红斑狼疮的药物(如糖皮质激素、免疫抑制剂和单抗类药物)不同,其通过多靶点途径恢复疾病状态下失衡的免疫内稳态,避免了单抗类药物常见的不良反应,安全性和耐受性良好。同时,马来酸蒿乙醚胺与现有青蒿素类药物相比,具有水溶性好、免疫抑制活性强、用药剂量低和口服方便等特点。

据悉,II期临床试验将在被确诊为轻中度系统性红斑狼疮的患者中开展。专家表示,如临床试验顺利推进,上市后将有望填补该领域小分子药物的空白,为患者提供新的治疗选择。

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