吸入LTI-03治疗异形性肺纤维化:随机剂量升级研究
medRxiv : the preprint server for health sciences
|November 24, 2025
概括
在一项1b期研究中,LTI-03是一种治疗异常性肺纤维化 (IPF) 的吸入疗法,证明了良好的安全性和耐受性. 生物标志物分析表明,IPF患者可能具有抗纤维和上皮保护作用.
科学领域:
- 肺部医学 肺部医学
- 药理学 药理学是指药理学的学科.
- 纤维化研究 纤维化研究
背景情况:
- 异形性肺纤维化 (IPF) 缺乏有效的治疗方法来阻止疾病的进展.
- 目前的IPF疗法往往会引起全身副作用,导致治疗中止.
- LTI-03是一种新型的吸入治疗药物,向洞穴支架域 (CSD) 来补充丢失的Cav-1信号,在临床前模型中显示出前景.
研究的目的:
- 在IPF患者中评估吸入LTI-03的安全性和药理动力学 (PK).
- 评估LTI-03对疾病生物标志物的影响.
- 在IPF患者中探索LTI-03的剂量相关影响.
主要方法:
- 阶段1b,随机,受控,剂量升级研究.
- 24名IPF参与者随机分为3:1到吸入LTI-03 (5或10毫克/天) 或安慰剂,持续14天.
- 主要终点:与治疗相关的不良事件 (TEAE);次要:血中的PK和生物标志物变化,PBMC和DBB.
主要成果:
- 吸入LTI-03的耐受性很好,TEAE轻度至中度;没有停止.
- 咳是最常见的TEAE.
- 在深层支气管刷术中,LTI-03降低了IL-11,CXCL7,TSLP和Galectin-7的表达,对原蛋白和SP-D有剂量相关的影响.
结论:
- 吸入的LTI-03在14天内在IPF患者中显示出良好的安全性和耐受性.
- 生物标志物数据表明,对上皮质平衡和抗纤维活性有积极影响.
- 这些结果支持在IPF的第二阶段疗效研究中对LTI-03进行进一步的研究.
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