Date: 2021-02-03
Type of information: Treatment of the first patient
phase: 3
Announcement: treatment of the first patient
Company: Vectivbio (Switzerland)
Product: apraglutide
Action mechanism: GLP-2 analog This next-generation GLP-2 analog is being developed for the treatment of short bowel syndrome (SBS). Patients with severe SBS require lifelong intravenous delivery of essential nutrients, referred to as parenteral support, for survival. Apraglutide aims to increase the intestine’s ability to absorb fluids and nutrients, thereby minimizing the burden of parenteral support. With a once-weekly dosing regimen, apraglutide is designed to have best-in-class properties with the goal of improving patients’ quality of life and their ability to thrive. In addition, apraglutide’s development program is designed to generate evidence of meaningful clinical benefit based on patients’ underlying intestinal anatomy in order to enable a patient-tailored treatment approach.
Disease: short bowel syndrome
Therapeutic area: Inflammatory diseases - Gastrointestinal diseases
Country: Argentina, Belgium, Czechia, France, Germany, Israel, Italy, Japan, republic of Korea, Poland, Spain, Sweden, Taiwan, UK, USA
Trial details: The phase 3 STARS (STudy of ApRaglutide in SBS) trial (NCT04627025) is a global clinical trial that represents the largest phase 3 trial ever conducted in short bowel syndrome with intestinal failure (SBS-IF). STARS is the first trial of a next-generation, long-acting GLP-2 analog, designed to exclusively evaluate a once-weekly dosing interval and to take into account remnant bowel anatomy and individual caloric needs during weaning patients off of parenteral support. The trial consists of a screening phase, a treatment phase of 48 weeks, and a safety follow-up phase.
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