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Final data from STARS Nutrition were presented at United European Gastroenterology Week 2023, demonstrating a significant reduction in parenteral support.
Ironwood Pharmaceuticals has announced positive final data from the phase 2 STARS Nutrition program evaluating the safety, pharmacokinetics, and efficacy of apraglutide in adult patients with short bowel syndrome with intestinal failure (SBS-IF) and colon-in-continuity (CIC).
Presented on October 16, 2023, at United European Gastroenterology Week, results showed 78% of patients gained 1 or more days off parenteral support and 100% of patients achieved clinical response by week 52, highlighting apraglutide’s ability to improve intestinal absorption.1
“These data are a strong testament to the durability of the effect of apraglutide on improving intestinal absorption and reducing [parenteral support] dependency in these patients,” said Tim Vanuytsel, MD, PhD, co-chair of the Leuven Intestinal Failure and Transplantation Center.1 “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.”
Positive interim results from STARS Nutrition were first announced in October 2022, revealing 6-month treatment with weekly apraglutide resulted in an average 50% reduction in parenteral support volume and a 47% reduction in parenteral energy content.2
An investigational, long-acting synthetic GLP-2 analog, apraglutide is a selective, full agonist of the GLP-2 receptor being developed for rare gastrointestinal diseases where GLP-2 can play a central role in addressing disease pathophysiology, including SBS-IF and acute graft-versus-host disease (aGVHD). In addition to the STARS Nutrition trial of apraglutide for SBS-IF, a phase 2 trial assessing the safety and efficacy of apraglutide in patients with steroid-refractory gastrointestinal aGVHD is ongoing and expected to be completed in 2025.1,3
STARS Nutrition, a multicenter, open-label, phase 2 metabolic balance study, was launched in June 2021 to assess the effect of once-weekly apraglutide 5 mg subcutaneous injection on intestinal absorption in patients with SBS-IF and CIC. Safety and parameters indicative of clinical efficacy, including parenteral support volume and energy content reduction, were examined.1
To be eligible for inclusion in the study, patients were required to be ≥ 18 years of age with SBS-IF and CIC, receive parenteral support secondary to surgical resection of the small intestine with <200 cm from duodenojejunal flexure, require parenteral support at least 2 days per week, and not have restorative surgery intended to change parenteral support requirements during the trial period. In total, 9 participants were enrolled in the study and given apraglutide subcutaneous injections once weekly during the 52-week evaluation period.3
The primary outcome of interest was the safety and tolerability of apraglutide, as measured by adverse events, clinical chemistry, hematology, hemostasis, anti-drug antibodies, and urine analysis. Secondary outcomes included change in actual weekly parenteral support volume from baseline, number of participants who achieve a reduction of at least 1 day per week of parenteral support, clinical response, energy reduction in the parenteral nutrition, and change in energy absorption.3
According to the release, 33% of patients achieved clinical response, defined as a parenteral support volume reduction of at least 20%, at 4 weeks. All 9 participants achieved clinical response by week 52. Parenteral support volume reduction reached a statistically significant 40% at week 24, further increasing to 52% at week 52.1
By the end of the study period, 78% of participants achieved at least 1 day off parenteral support and all 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 parenteral support at baseline. Of note, apraglutide was well tolerated with an acceptable safety profile.1
“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, vice president of apraglutide life cycle leadership at Ironwood Pharmaceuticals.1 “We welcome these results and are continuing to progress the apraglutide development in the SBS-IF program with a sense of urgency.”