Ironwood Pharma Reveals Positive Final Data From STARS Nutrition Phase II Study Of Apraglutide

(RTTNews) - Ironwood Pharmaceuticals, Inc. (IRWD) announced Monday positive final data from Phase II STARS Nutrition study of Apraglutide in short bowel syndrome with intestinal failure or SBS-IF and Colon-in-Continuity or CIC.

SBS-IF is a severe organ failure condition due to a reduction in intestinal function below the minimum necessary for nutrient and fluid absorption. Patients with CIC, who have a preserved colon with the remnant small intestine, represent over 55% of the SBS-IF population.

The company said the 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 multicenter study of nine patients evaluated 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 SBS-IF and CIC.

The company had announced positive interim results from the study in October 2022.

The GI-focused healthcare company presented the data during United European Gastroenterology or UEG Week.

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 or PS volume and energy content decrease, resulting in one or more days off PS.

According to the company, 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.

Tim Vanuytsel, gastroenterologist, Co-Chair of the Leuven Intestinal Failure and Transplantation Center and lead investigator, said, "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. 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."

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