金吾财讯 | 全球创新免疫学企业argenx SE（ARGX）公布了其三期ALKIVIA临床试验的积极顶线数据。该试验评估了皮下注射药物VYVGART Hytrulo在成人自身免疫性肌炎中的疗效，包括免疫介导的坏死性肌病（IMNM）和皮肌炎（DM）。
数据披露，在IMNM与DM的合并研究人群中，经过52周治疗，Vyvgart Hytrulo组的平均总改善评分（TIS）较安慰剂组显著高出15.4分（47.95分vs32.56分，p=0.0011），达到主要终点。在IMNM亚组分析中，治疗组同样展现出14.8分的显著改善（p=0.0048）。这是全球首个在没有任何批准疗法的IMNM领域取得统计学显著与临床意义改善的三期临床试验。患者在治疗第4周即出现显著改善，且在伴随糖皮质激素减量的过程中，疗效持续稳定保持了一整年。药物耐受性良好，安全性特征与已知安全数据一致。自身免疫性肌炎属于罕见且高度致残的疾病，长久以来临床严重依赖大剂量激素和广谱免疫抑制剂。医学专家指出，通过精确定向阻断新生儿Fc受体（FcRn）来降低致病性IgG自身抗体，为该类疾病开辟了靶向治疗的新路径。
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.