Ironwood Pharmaceuticals Inc (NASDAQ:IRWD) released topline results from its pivotal Phase 3 STARS trial of once-weekly subcutaneous apraglutide in reducing parenteral support (PS) (drugs given by routes other than the digestive tract) dependency in adult patients with short bowel syndrome with intestinal failure (SBS-IF).
SBS-IF, a rare and severe organ failure condition in which patients are dependent on PS, affects an estimated 18,000 adult patients in the U.S., Europe, and Japan.
The trial met its primary endpoint of relative change from baseline in actual weekly PS volume at week 24, comparing apraglutide versus placebo (-25.5% vs. -12.5%).
In addition, there were four key secondary endpoints evaluated in statistical ...