Ironwood Pharmaceuticals Presents Positive Final Data from STARS Nutrition, a Phase II Study of Apraglutide in Short Bowel Syndrome with Intestinal Failure (SBS-IF) and Colon in Continuity (CIC) at United European Gastroenterology Week

Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a global GI-focused healthcare company, presented positive final data from the company’s Phase II STARS Nutrition program during United European Gastroenterology (UEG) Week. This multicenter study of nine patients was designed to evaluate the safety, pharmacokinetics, and efficacy of apraglutide, an investigational next-generation, long-acting synthetic GLP-2 analog, on intestinal absorption in adult patients who have Short Bowel Syndrome with Intestinal Failure (SBS-IF) and Colon-in-Continuity (CIC). Positive interim results from this study were first announced in October 2022.

The data from STARS Nutrition were featured at UEG Week during a late-breaker oral presentation titled “The Long-Acting GLP-2 Analog Apraglutide Provides Clinical Benefit For Patients With Short Bowel Syndrome With Intestinal Failure And Colon In Continuity At 52 Weeks.” The presentation highlighted that apraglutide had an acceptable safety profile, which was the primary study objective, and that apraglutide improved intestinal absorption as indicated by 50% parenteral support (PS) volume and energy content decrease, resulting in one or more days off PS. PS reduction was observed as early as week four and was maintained until the end of the study. Seventy-eight percent (78%) of patients gained one or more days off PS with all patients achieving clinical response.

SBS-IF is a severe organ failure condition due to a reduction in intestinal function below the minimum necessary for nutrient and fluid absorption, leading to dependence on life-long PS to maintain health, growth, and survival. The most severe cases require PS (including parenteral nutrition and/or intravenous fluid) infusions for up to 10 to 15 hours per day. An estimated 17,000 people are thought to suffer from SBS-IF in the U.S. and Europe. Patients with CIC who have a preserved colon with the remnant small intestine, represent over 55% of the SBS-IF population with a large unmet need. STARS Nutrition study is the first-ever study designed to evaluate the clinical benefit of a GLP-2 analog specifically in patients with SBS-IF with CIC.

“In order to secure adequate nutrition and hydration – the fundamental elements of survival – people with SBS-IF-CIC endure a significant impact on quality of life and run the risk of severe complications such as infection,” said Tim Vanuytsel, M.D., Ph.D., gastroenterologist, Co-Chair of the Leuven Intestinal Failure and Transplantation Center and lead investigator. “These data are a strong testament to the durability of the effect of apraglutide on improving intestinal absorption and reducing PS dependency in these patients, and reinforce the interim results announced last year. The STARS Nutrition study with apraglutide represents a significant advance in understanding GLP-2 and how we can help all patients with SBS-IF, including those with colon in continuity. The benefits observed here could have a major impact on clinical care and improving patient's quality of life if confirmed in the ongoing STARS pivotal trial.”