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CSL Posts Encouraging Data From Garadacimab In Severe Swelling Attacks

CSL Posts Encouraging Data From Garadacimab In Severe Swelling Attacks

中超發佈Garadacimab在嚴重腫脹發作中令人鼓舞的數據
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(場外交易代碼：CSLLY)宣佈了Garadacimab(CSL312)治療遺傳性血管性水腫(HAE)的TOPLINE第三階段結果。
  • HAE是一種罕見的遺傳疾病，會導致腹部、喉嚨、面部和四肢以及身體其他部位的疼痛、虛弱和不可預測的腫脹發作。
  • 這項研究達到了其主要和次要療效目標，並顯示出良好的安全性和耐受性。
  • CSL的目標是在本財年結束時開始向全球衞生當局提交全面批准文件。
  • 這項研究的全部結果將在即將召開的科學大會上公佈，並發表在同行評議的期刊上。
  • Garadacimab是一種新型的凝血因子XIIa抑制單抗(FXIIa MAb)，目前處於3期臨牀開發階段，是一種每月一次的皮下預防HAE相關發作的新型藥物。
  • Garadacimab獨一無二地抑制血漿蛋白FXIIa。當FXIIa被激活時，它啟動了導致水腫形成的事件的下跌。通過靶向FXIIa，Garadimab抑制了下跌的HAE。
  • 該藥物已獲得FDA和歐洲藥品管理局的孤兒藥物稱號。
  • CSL還在研究garadacimab在HAE以外的其他適應症，在這些情況下，抑制FXIIa可能在改善臨牀結果方面發揮關鍵作用，包括肺纖維化。
  • 價格行動：在週三的最後一次檢查中，CSLLY股價下跌3.18%，至100.82美元。
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