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CSL Posts Encouraging Data From Garadacimab In Severe Swelling Attacks

CSL Posts Encouraging Data From Garadacimab In Severe Swelling Attacks

中超发布Garadacimab在严重肿胀发作中令人鼓舞的数据
Benzinga Real-time News ·  2022/08/17 12:14
  • CSL (OTC:CSLLY) announced topline Phase 3 results for garadacimab (CSL312) for hereditary angioedema (HAE). 
  • HAE is a rare genetic condition that causes painful, debilitating, unpredictable episodes of swelling of the abdomen, larynx, face, and extremities, among other body areas. 
  • The study met its primary and secondary efficacy objectives and demonstrated favorable safety and tolerability. 
  • CSL aims to begin filing with global health authorities at the end of the current fiscal year for full approval.
  • Full results from the study will be presented at an upcoming scientific congress and published in a peer-reviewed journal.
  • Garadacimab is a novel Factor XIIa-inhibitory monoclonal antibody (FXIIa mAb) currently in Phase 3 clinical development as a new type of once-monthly subcutaneous prophylactic treatment for attacks related to HAE. 
  • Garadacimab uniquely inhibits the plasma protein FXIIa. When FXIIa is activated, it initiates the cascade of events leading to edema formation. By targeting FXIIa, garadacimab inhibits the HAE cascade.
  • The drug has received orphan-drug designation from the FDA and European Medicines Agency.
  • CSL is also investigating garadacimab for other indications beyond HAE, where FXIIa inhibition may play an essential role in improving clinical outcomes, including pulmonary fibrosis.
  • Price Action: CSLLY shares are trading lower by 3.18% at $100.82 on the last check Wednesday.
  • CSL(场外交易代码：CSLLY)宣布了Garadacimab(CSL312)治疗遗传性血管性水肿(HAE)的TOPLINE第三阶段结果。
  • HAE是一种罕见的遗传疾病，会导致腹部、喉咙、面部和四肢以及身体其他部位的疼痛、虚弱和不可预测的肿胀发作。
  • 这项研究达到了其主要和次要疗效目标，并显示出良好的安全性和耐受性。
  • CSL的目标是在本财年结束时开始向全球卫生当局提交全面批准文件。
  • 这项研究的全部结果将在即将召开的科学大会上公布，并发表在同行评议的期刊上。
  • Garadacimab是一种新型的凝血因子XIIa抑制单抗(FXIIa MAb)，目前处于3期临床开发阶段，是一种每月一次的皮下预防HAE相关发作的新型药物。
  • Garadacimab独一无二地抑制血浆蛋白FXIIa。当FXIIa被激活时，它启动了导致水肿形成的事件的下跌。通过靶向FXIIa，Garadimab抑制了下跌的HAE。
  • 该药物已获得FDA和欧洲药品管理局的孤儿药物称号。
  • CSL还在研究garadacimab在HAE以外的其他适应症，在这些情况下，抑制FXIIa可能在改善临床结果方面发挥关键作用，包括肺纤维化。
  • 价格行动：在周三的最后一次检查中，CSLLY股价下跌3.18%，至100.82美元。
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