VectivBio Announces Start of Phase 3 Trial

The phase 3 STARS (STudy of ApRaglutide in SBS) trial 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 phase 2 clinical program for apraglutide included two independent trials evaluating the safety and efficacy of once-weekly administration in patients with SBS. Apraglutide was found to be safe and well tolerated in both trials and achieved clinically meaningful improvement in intestinal fluid and nutrient absorption compared with placebo. The trials supported the potential advantages of apraglutide on energy absorption to improve outcomes for patients with SBS. These data, as well as those from a metabolic balance trial, were presented at the 2020 ESPEN Virtual Congress and are available in Clinical Nutrition ESPEN.

"SBS is a devastating and life-threatening condition with great unmet medical need, for which the standard-of-care presents a significant daily burden for people living with SBS, their families and caregivers," said Luca Santarelli, M.D., Chief Executive Officer of VectivBio. "We are excited to commence patient dosing in our pivotal phase 3 trial which was designed with feedback from the FDA and the EMA. We see the potential for apraglutide to become the best-in-class GLP-2 analog."

Short Bowel Syndrome (SBS) is a malabsorptive disorder caused by the loss of functional small intestine. The severity of SBS ranges across an anatomical spectrum, and 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). As an organ failure condition with unmet medical need, 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.