智通财经APP讯，歌礼制药-B(01672)发布公告，其治疗轻中度斑块状银屑病的ASC50的 I期新药临床试验申请(IND)已于近期获美国食品药品监督管理局(FDA)批准。 ASC50为歌礼自主研发的口服小分子白细胞介素-17(IL-17)靶向抑制剂，该靶点在银屑病等多种自身免疫及炎症性疾病领域已获充分的生物学验证并具备成熟商业价值。
在非人灵长类动物(NHPs)中口服给药后，与当前正处于临床开发阶段的某口服小分子IL-17抑制剂相比，ASC50的药物暴露量更高，半衰期更长以及清除率更低。此外，在银屑病动物模型中，ASC50显示出强药效。这些临床前数据支持ASC50 有望成为每日一次口服治疗银屑病的同类最佳(best-in-class)候选药物。
ASC50的该项I期临床试验为随机、双盲、安慰剂对照的研究，将在美国多个中心开展，预计将于2025年第叁季度开始在轻中度斑块状银屑病人中给药。
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