VectivBio Holding AG , 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).
Phase 2 trial will evaluate the efficacy of once-weekly apraglutide in increasing intestinal energy absorption in CIC patients with SBS-IF
CIC patients represent over half of the total SBS-IF population
Initial readout of 4-week intestinal energy absorption data expected in 1H22
BASEL, Switzerland, June 15, 2021 (GLOBE NEWSWIRE) -- 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.
About VectivBio AG
VectivBio (Nasdaq:VECT) is a global, clinical-stage biotechnology company focused on the discovery, development and commercialization of innovative treatments for severe rare conditions with high unmet medical need. The company is committed to pursuing product candidates with a clear mechanism of action and the potential to meaningfully transform and improve the lives of patients and their families. VectivBio’s product candidate, apraglutide, is a next-generation GLP-2 analog being developed as a differentiated therapeutic for a range of rare gastrointestinal (GI) diseases. Apraglutide is currently being evaluated in a global Phase 3 clinical trial as a once-weekly treatment for short bowel syndrome with intestinal failure (SBS-IF). VectivBio also plans to initiate clinical studies of apraglutide in additional indications, including graft versus host disease, where GLP-2 is believed to be central to disease pathophysiology.
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About Short Bowel Syndrome
Short bowel syndrome (SBS) is a malabsorption disorder caused by the loss of functional small intestine. SBS typically occurs in adults due to irreparable gastrointestinal damage caused by physical trauma, Crohn’s disease, ulcerative colitis, ischemia or cancer, which require surgeries that result in the removal of large portions of the small intestine or colon. The severity of SBS can vary depending upon the length and function of the remaining portion of the intestine. Some patients who are initially diagnosed with intestinal insufficiency suffer from progressively worse food and fluid absorption, leading to SBS with chronic intestinal failure (SBS-IF). Patients with SBS-IF require parenteral support (PS), the intravenous delivery of essential fluids and nutrients, to survive. Patients with the most severe SBS-IF require PS infusions for up to 10 to 15 hours per day. SBS is associated with frequent complications, significant morbidity and mortality, high economic burden and an impaired quality of life. An estimated 32,000 people are thought to suffer from SBS in the U.S. and Europe, of whom 15,000 suffer from SBS-IF and require lifelong PS.
About Apraglutide
Apraglutide is an investigational drug being evaluated in a pivotal phase 3 clinical trial as a once-weekly treatment for patients who have short bowel syndrome with intestinal failure (SBS-IF). It is a next-generation, long-acting synthetic GLP-2 analog that acts as a selective, full agonist of the GLP-2 receptor. Apraglutide is designed to enable patients to minimize the burden from parenteral support by increasing intestinal absorption of fluids, calories and nutrients. Based on preclinical and clinical data to date, apraglutide has the potential to advance the treatment of SBS-IF by establishing less frequent dosing and improving clinical outcomes for patients across the anatomical spectrum that characterizes the disease.
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