Ironwood’s apraglutide meets Phase 3 endpoint in Short Bowel Syndrome

Ironwood will present late-breaking data during the 2024 Digestive Disease Week meeting from its pivotal Phase III clinical trial, STARS, which evaluated the efficacy and safety of once-weekly subcutaneous apraglutide in adult patients with short bowel syndrome with intestinal failure – SBS-IF -. Based on these results, the company is working to submit a new drug application to the FDA and marketing applications to other regulatory agencies for apraglutide for the treatment of adult patients with SBS who are dependent on parenteral support. SBS-IF, a rare chronic debilitating malabsorptive condition in which patients are dependent on PS, affects an estimated 18,000 adult patients in the U.S., Europe, and Japan. Ironwood previously reported that the STARS clinical trial met its primary endpoint of relative change from baseline in actual weekly PS volume at week 24 vs. placebo. Findings from the late-breaking presentation include: significantly more apraglutide-patients gained additional days off from PS per week at week 24 versus placebo; significantly more apraglutide-treated patients in the overall and the stoma populations were clinical responders and clinical high responders. Apraglutide also demonstrated statistical significance on two key secondary endpoints, with more patients in the combined population achieving at least one day/week off PS relative to baseline at week 24 versus placebo and more patients treated with apraglutide versus placebo demonstrating improvement in relative change from baseline in actual weekly PS volume. Apraglutide was well-tolerated, with no new safety signals identified and the safety profile was consistent with previous apraglutide studies. In addition to the STARS Phase III oral presentation, Ironwood, and its collaborators presented further data highlighting findings across the apraglutide development program.