Ironwood Pharmaceuticals Reports Results for Apraglutide in P-III Trial for the Treatment of Short Bowel Syndrome with Intestinal Failure (SBS-IF)
Shots:
- The P-III (STARS) trial evaluates the efficacy & safety of apraglutide (QW) vs PBO in reducing parenteral support (PS) dependency among SBS-IF patients. The 1EP was a relative change from baseline in weekly PS volume at wk.24 & the 2EPs had 4 criteria
- The study met its 1EP by depicting a change in PS volume by -25.5% vs -12.5% & 2 2EPs with 43% vs 27.5% of patients having at least 1 day/week off PS at wk.24 & -25.6% vs -7.8% of patients depicting improvement in relative change from baseline in actual weekly PS volume
- 2EPs of colon-in-continuity patients having at least one day/week off PS vs baseline & reaching enteral autonomy at wk.48 were not achieved. Based on these results the company expects to file NDA & other regulatory filings
Ref: Ironwood Pharmaceuticals | Image: Ironwood Pharmaceuticals
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
