Benzinga | Jun 15, 2021 07:16AM EDT

VectivBio Announces First Patient Dosed in Metabolic Balance Study of Apraglutide in Colon-in-Continuity Patients with Short Bowel Syndrome with Intestinal Failure

VectivBio Holding AG, ("Vectiv" or "VectivBio") (NASDAQ:VECT), 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, today 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.

"SBS patients with colon-in-continuity are in desperate need of a new medicine," said Luca Santarelli, M.D., Ph.D., Founder and CEO of VectivBio. "Recent SBS-IF research shows that CIC patients are physiologically distinct in their response to GLP-2 analogs when compared to stoma patients. Specifically, CIC patients require fewer fluid infusions than stoma patients and may be more likely to achieve enteral autonomy in response to GLP-2 analogs. The purpose of this Phase 2 metabolic balance study is to demonstrate that apraglutide improves intestinal absorption in CIC patients, which may help them improve their enteral autonomy by decreasing or eliminating the need of parenteral support."

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.

"Remnant bowel anatomy is a key determinant in how SBS-IF patients will respond to GLP-2 treatment," said Tim Vanuytsel, M.D., Ph.D., gastroenterologist, Co-Chair of the Leuven Intestinal Failure and Transplantation Center and lead investigator. "Although, the mechanistic effects of GLP-2 therapy across SBS-IF patients remains consistent, the length and function of the remaining portion of the bowel determines the type and severity of symptoms. Based on CIC patients' greater ability to absorb water naturally than stoma patients, there is scientific and clinical rationale to focus on nutrient absorption rather than fluid response in this group."

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.