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Ironwood Pharmaceuticals Will Present Late-breaking Data During The 2024 Digestive Disease Week Meeting From Its Phase 3 STARS Trial Of Apraglutide For Short Bowel Syndrome With Intestinal Failure

Ironwood Pharmaceuticals Will Present Late-breaking Data During The 2024 Digestive Disease Week Meeting From Its Phase 3 STARS Trial Of Apraglutide For Short Bowel Syndrome With Intestinal Failure

Ironwood Pharmicals將在2024年消化系統疾病週會議上公佈其Apraglutide治療腸衰竭短腸綜合徵的三期STARS試驗的最新數據
Benzinga ·  05/21 06:13
  • New data highlight both stoma and colon-in-continuity (CIC) patients drove the positive primary endpoint with significant relative change from baseline in weekly parenteral support (PS) volume reduction at week 24
  • Additional secondary endpoints show significant increases in days off PS and clinical responder rates with apraglutide, including achieving enteral autonomy in both stoma and CIC patients –
  • Data from largest GLP-2 Phase III study to date adds to body of evidence on safety and efficacy of once-weekly apraglutide in adults with SBS-IF –
  • New details on safety and tolerability to be presented; showing apraglutide to be well tolerated with a safety profile consistent with previously reported apraglutide studies in this patient population
  • 新數據顯示,造口和結腸連續性(CIC)患者均爲陽性主要終點,第24周每週腸外支持(PS)量減少與基線相比有顯著的相對變化
  • 其他次要終點顯示,阿普拉魯肽的休假天數和臨床反應率顯著增加,包括實現造口和CIC患者的腸內自主權—
  • 迄今爲止最大的 GLP-2 III 期研究的數據增加了關於每週一次的阿普拉魯肽對成人 SBS-IF 的安全性和有效性的證據—
  • 有關安全性和耐受性的新細節將公佈;顯示阿普拉魯肽具有良好的耐受性,其安全性與先前報告的針對該患者群體的apraglutide研究一致
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