Ironwood Pharmaceuticals, Inc. (IRWD), a GI-focused healthcare company, announced Thursday positive topline results from its Apraglutide Phase III STARS trial in adults with short bowel syndrome with intestinal failure or SBS-IF. The trial met its primary endpoint.
Meanwhile, in the four key secondary endpoints, the third and fourth key secondary endpoints were specific to colon-in-continuity patients in assessing at least one day/week off parenteral support or PS versus baseline and reaching enteral autonomy at week 48, both of which were not achieved.
In pre-market activity on Nasdaq, Ironwood shares were losing around 25 percent to trade at $11.39.
The global, multicenter, double-blind, randomized, placebo-controlled trial evaluated the efficacy and safety of once-weekly subcutaneous injections of apraglutide in reducing PS dependency in adult patients with SBS-IF, a rare and severe organ failure condition.
The trial met its primary endpoint of relative change from baseline in actual weekly PS volume at week 24, comparing apraglutide versus placebo.
Apraglutide demonstrated statistical significance for the first two key secondary endpoints.
The company noted that Apraglutide was numerically favorable but not statistically significant relative to placebo for improving days off PS and reaching enteral autonomy in seven out of 56 patients versus two out of 27 patients on placebo.
Based on these positive results, Ironwood plans to submit a new drug application or NDA and other regulatory filings for apraglutide for use in adult patients with SBS who are dependent on PS.
Kishore R Iyer, MBBS, FRCS (Eng), FACS, Coordinating Principal Investigator of the trial, said, "The STARS topline results are significant as this is the first successful Phase III placebo-controlled study in SBS-IF patients with a GLP-2 analog with once-weekly dosing."
The company noted that Apraglutide was generally well-tolerated. Topline safety results were generally consistent with the safety profile demonstrated in apraglutide studies to date.
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