VectivBio Holding AG announced the completion of enrollment of the Colon-in-Continuity (CIC) cohort for the company's Phase 3 STARS (STudy of ApRglutide in SBS) pivotal study investigating the long-acting synthetic GLP-2 agonist apraglutide in Short Bowel Syndrome with Intestinal Failure (SBS-IF). STARS is a pivotal, global Phase 3 study enrolling approximately 144 patients with SBS-IF stratified 50/50 for CIC and stoma, with patients being evaluated over 48 weeks and 24 weeks respectively. This stratification will allow for the evaluation of anatomy-specific key secondary endpoints.

Patients are randomized 2:1 for either once-weekly-apraglutide or placebo. The study includes an improved PS weaning algorithm tailored to remnant bowel anatomy to enhance signal detection. STARS is designed to establish a new standard of care for all patients with SBS-IF and to tailor apraglutide treatment to patients with distinct remnant bowel anatomy.

The Phase 3 study is being conducted globally in 18 countries and over 80 sites.