VectivBio Announces Completion of Enrollment for Colon-In-Continuity (CIC) Cohort of STARS Pivotal Phase 3 Study Investigating Apraglutide in Short Bowel Syndrome with Intestinal Failure (SBS-IF)
-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.”
Apraglutide is an investigational new drug that is a next-generation, long-acting synthetic GLP-2 analog being developed for a range of rare gastrointestinal diseases where GLP-2 can play a central role in addressing disease pathophysiology, including short bowel syndrome with intestinal failure (SBS-IF) and Acute Graft-Versus-Host Disease (aGVHD).
About VectivBio AG
VectivBio is a global clinical-stage biotechnology company focused on transforming and improving the lives of patients with severe rare conditions. Lead product candidate apraglutide is a next-generation, long-acting synthetic GLP-2 analog being developed for a range of rare gastrointestinal diseases where GLP-2 can play a central role in addressing disease pathophysiology, including short bowel syndrome with intestinal failure (SBS-IF) and Acute Graft-Versus-Host Disease (aGVHD).
VectivBio is also advancing its modular, small molecule CoMET platform to address a broad range of previously undruggable Inherited Metabolic Diseases (IMDs). CoMET leverages innovative chemistry, based on a proprietary stabilized pantetheine backbone, to restore fundamental cellular metabolism in pediatric populations with IMDs characterized by a deficit of energy metabolism caused by the depletion of functional Coenzyme A (“CoA”). Candidates from the CoMET platform are initially being evaluated in methylmalonic acidemia (MMA), propionic acidemia (PA), and other organic acidemias.
Forward Looking Statements
Forward-looking statements are statements that are not historical facts. Words and phrases such as “anticipated,” “forward,” “will,” “would,” “may,” “remain,” “potential,” “prepare,” “expected,” “believe,” “plan,” “near future,” “belief,” “guidance,” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements concerning the clinical development of apraglutide, as well as interim data and potential upcoming data readouts from VectivBio’s STARS Nutrition clinical trial, and statements regarding VectivBio’s CoMET platform. All of such statements are subject to risks and uncertainties, many of which are difficult to predict and generally beyond VectivBio’s control, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. Such risks and uncertainties include, but are not limited to: the impacts of the Russian/Ukrainian war and the ongoing COVID-19 pandemic, including interruptions or other adverse effects on clinical trials and delays in regulatory review; delay in or failure to obtain regulatory approval of VectivBio’s product candidates and successful compliance with FDA and other governmental regulations applicable to product approvals; the risks inherent in drug development and in conducting clinical trials; and those risks and uncertainties identified in the “Risk Factors” section of VectivBio’s Annual Report for the year ending December 31, 2021 on Form 20-F filed with the Securities and Exchange Commission on April 7, 2022. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, VectivBio undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
VectivBio SVP, Investor Relations and Strategic Communications