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 - Seite 2

The study showed that PS reduction was observed 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 week compared to a mean of 5.2 days per week on PS at baseline, which allowed patients more independence. Apraglutide was well tolerated with an acceptable safety profile.

“These positive data are a crucial advancement that highlight the potential of apraglutide to be a best-in-class GLP-2 analog for the whole spectrum of patients with SBS-IF, including those with CIC,” said Jana Noeldeke, apraglutide life cycle leader and head of Ironwood Pharmaceuticals’ site at Basel, Switzerland. “We welcome these results and are continuing to progress the apraglutide development in the SBS-IF program with a sense of urgency.”

About STARS Nutrition

STARS Nutrition is the first-ever study to prospectively evaluate the clinical benefit of a GLP-2 analog specifically in patients with CIC. This multicenter, open-label Phase II metabolic balance study was designed to evaluate the effect of once-weekly apraglutide 5-mg subcutaneous injection on intestinal absorption in SBS-IF patients with CIC at 52 weeks. Safety and parameters indicative of clinical efficacy, including PS volume and energy content reduction, were assessed. The study enrolled nine adult patients with a mean age of 46.8 years.

About Short Bowel Syndrome with Intestinal Failure

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. In adults, it is typically caused by irreparable GI damage due to inflammatory bowel disease, ischemia, physical trauma, or surgical resection of large portions of the small intestine. SBS-IF is an anatomically heterogeneous condition in which the type of remnant bowel anatomy, such as CIC or stoma, determines the therapeutic goal, medical needs, clinical response, and the individual patient journey. 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 17,000 people are thought to suffer from SBS-IF in the U.S. and Europe and require lifelong PS.