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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米生物製藥公司宣佈伏魯替丁治療短腸綜合徵第二階段研究的初步結果
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
  • 第二階段：Vibrant研究確定了一個劑量和給藥間隔，在6周內24小時平均總排便量減少的主要終點改善了25%以上
  • Vurolenatide總體耐受性良好，沒有不良事件導致早期研究停用
  • 與FDA的第二階段會議定於第三季度中期結束
  • Vurolenatide的第三階段研究最早可能在2022年第四季度開始，等待第二階段會議結束的結果；研究規劃和後勤工作正在順利進行

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