Ironwood Pharmaceuticals, Inc. 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% 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. The study showed that PS reduction was seen as early as 4 weeks after PS weaning was allowed with 33% of the patients achieving clinical response.

PS volume reduction reached a statistically significant 40% at week 24 and the effect was maintained with a 52% volume reduction at week 52. All patients were clinical responders, defined as those achieving a PS volume reduction of at least 20%. At week 52, seven out of the nine patients (78%) achieved at least one day off PS.

At week 52, patients gained an additional 2.1 (0.7 - 3.6) days off per day.