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将在2024年消化系统疾病周会议上公布其Apraglutide治疗肠衰竭短肠综合征的三期STARS试验的最新数据
- 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
- 新数据显示，造口和结肠连续性（CIC）患者均为阳性主要终点，第24周每周肠外支持（PS）量减少与基线相比有显著的相对变化
- 其他次要终点显示，阿普拉鲁肽的休假天数和临床反应率显著增加，包括实现造口和CIC患者的肠内自主权—
- 迄今为止最大的 GLP-2 III 期研究的数据增加了关于每周一次的阿普拉鲁肽对成人 SBS-IF 的安全性和有效性的证据—
- 有关安全性和耐受性的新细节将公布；显示阿普拉鲁肽具有良好的耐受性，其安全性与先前报告的针对该患者群体的apraglutide研究一致
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