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-Largest global Phase 3 study ever conducted in SBS-IF recruiting a total of 144 patients, stratified 50/50 for Stoma and CIC anatomical subtypes
-First Phase 3 study to prospectively evaluate safety and efficacy of a GLP-2 agonist in SBS-IF according to patient’s remnant bowel anatomy
-Top-line Phase 3 results expected at the end of 2023
BASEL, Switzerland, Nov. 03, 2022 (GLOBE NEWSWIRE) -- VectivBio Holding AG (“VectivBio”) (NASDAQ:VECT), a clinical-stage biopharmaceutical company pioneering novel transformational treatments for severe rare conditions, today 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).
“Achieving the enrollment target for the CIC cohort is an important milestone which keeps us on track to readout top-line results for the Phase 3 STARS Trial by the end of 2023,” said Luca Santarelli, M.D., Founder and Chief Executive Officer of VectivBio. “This result is a testament to a successful operational effort based on our strong partnership with patients and investigators involved in this study”.
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.
“This important study is designed to establish the therapeutic effects of apraglutide, to confirm the safety and efficacy demonstrated in the Phase 2 studies and to support a potentially differentiated label claim of benefit in both CIC and stoma patients,” said Omar Khwaja, M.D., Ph.D., Chief Medical Officer of VectivBio. “We look forward to building upon our development of apraglutide as a treatment option for all SBS-IF patients.”
Posted In: VECT
