Clinical Trials

Date: 2021-06-15

Type of information: Treatment of the first patient

phase: 2

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 with intestinal failure (SBS-IF)

Therapeutic area: Inflammatory diseases - Gastrointestinal diseases

Country: Belgium

Trial details: STARS Nutrition is a multicenter, open-label Phase 2 Metabolic Balance Study of Apraglutide in Patients with SBS-IF and Colon-in-Continuity trial designed to evaluate the efficacy of once-weekly apraglutide in increasing intestinal energy absorption in SBS-IF CIC patients. The trial is expected to enroll approximately 10 patients and will measure their calorie absorption at weeks 4 and 48. Secondary endpoints will assess changes in PS volume. The initial readout of 4-week absorption data is expected in the first half of 2022. (NCT04964986)

Latest news:

  • On June 15, 2021, VectivBio, a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of innovative treatments for severe rare conditions for which there is a significant unmet medical need, announced it has dosed the first patient in its Phase 2 STARS Nutrition metabolic balance study evaluating apraglutide in colon-in-continuity (CIC) patients with short bowel syndrome with intestinal failure (SBS-IF). CIC patients represent over half of the total short bowel syndrome with intestinal failure population and are underserved by current treatment options.
  • CIC patients represent approximately 55% of the SBS-IF population and do not require a stoma bag because they have a preserved colon, in continuity with the upper intestine. The presence of a functional colon allows CIC patients to absorb sufficient levels of water through normal oral ingestion and, therefore, receive lower volumes of parenteral support (PS). Historically, clinical trials evaluating the efficacy of GLP-2 analogs in SBS-IF have assessed stoma and CIC patients together and focused on total PS volume reductions, with an emphasis on fluids vs. energy absorption. While appropriate for stoma patients, this approach has limited utility in assessing clinical benefit in CIC patients. Recent research has demonstrated that the monitoring of metabolic parameters, such as energy absorption, are the most sensitive method to assess efficacy of GLP-2 analog treatment in CIC patients. In a previous VectivBio study, apraglutide was the first GLP-2 analog to demonstrate statistically significant enhancements in energy absorption in a Phase 2 trial and with a weekly dosing regimen.

Is general: Yes