JAK抑制剂联合疗法FMX114治疗轻中度特应性皮炎,临床试验中招募了第一位患者

2021-10-20 Allan MedSci原创

FMX114是VYNE专有的托法替尼和芬戈莫德的组合凝胶制剂。

特应性皮炎 (AD) 是一种慢性、严重的湿疹,其特征是皮肤干燥、发红和发痒。AD最常影响脸颊、手臂和腿部。经常会出现突然发作,症状可能会恶化,导致更剧烈的瘙痒和更多的开放性溃疡。 AD耀斑是由压力、温度变化、汗水、各种皮肤刺激物和过敏引起的。AD可以对生活质量产生广泛的影响。虽然AD最常发生在儿童身上,但它可以在一个人一生中的任何时候发展,仅在美国就有大约3000万人受到影响。诊断出的患者中约有2200万人正在接受治疗,其中1900万人患有轻度至中度疾病。皮疹往往会爆发并消失,但随后又会复发。

VYNE Therapeutics今天宣布已其Ib/IIa期临床试验招募了第一位患者,该试验评估FMX114治疗轻中度特应性皮炎。FMX114是VYNE专有的托法替尼和芬戈莫德的组合凝胶制剂。该产品正在开发中,通过开发托法替尼(一种Janus激酶抑制剂)和芬戈莫德(一种鞘氨醇1-磷酸受体调节剂)的独特组合,来解决AD中炎症的来源和原因。FMX114可通过抑制炎症细胞的迁移来减少炎症,此外还可以直接支持皮肤屏障的恢复。FMX114有可能成为第一个用于治疗AD的局部联合JAK抑制剂。

Ib/IIa期研究是一项随机、双盲试验,旨在比较FMX114凝胶与载体凝胶的安全性和有效性。该研究预计将招募31名受试者,每个受试者作为自己的对照。入组标准规定受试者在进入时必须有两个可比较的AD病变。参与者将FMX114凝胶应用于这些病变之一,并将载体凝胶应用于另一个。六名受试者最初每天接受两次FMX114和载体治疗长达两周,以评估FMX114的初步安全性以及托法替尼、芬戈莫德和芬戈莫德 1-磷酸盐的药代动力学。另外25名受试者将在研究的双盲阶段接受FMX114和载体治疗,每天两次,持续四个星期,以进一步评估安全性、药代动力学和功效。

 

原始出处:

https://www.firstwordpharma.com/node/1872499?tsid=4

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    2022-08-30 jklm09
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    2021-10-21 呼吸科小医生

    学习了很多

    0

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