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9 Meters Biopharma Announces Preliminary Results From Phase 2 Study Of Vurolenatide In Short Bowel Syndrome

9 Meters Biopharma Announces Preliminary Results From Phase 2 Study Of Vurolenatide In Short Bowel Syndrome

9米生物制药公司宣布伏鲁替丁治疗短肠综合征第二阶段研究的初步结果
Benzinga Real-time News ·  2022/06/30 19:10
  • Phase 2 VIBRANT study identifies a dose and dosing interval with >25% improvement in the primary endpoint of 24-hour mean total stool output reduction over 6 weeks
  • Vurolenatide was generally well tolerated with no adverse events leading to early study withdrawal
  • End-of-Phase 2 meeting with FDA scheduled for mid-third quarter
  • Phase 3 study for vurolenatide could begin as early as fourth quarter 2022 pending outcome of end-of-Phase 2 meeting; Study planning and logistics well underway
  • 第二阶段：Vibrant研究确定了一个剂量和给药间隔，在6周内24小时平均总排便量减少的主要终点改善了25%以上
  • Vurolenatide总体耐受性良好，没有不良事件导致早期研究停用
  • 与FDA的第二阶段会议定于第三季度中期结束
  • Vurolenatide的第三阶段研究最早可能在2022年第四季度开始，等待第二阶段会议结束的结果；研究规划和后勤工作正在顺利进行

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