Kishore Iyer, MBBS, MSc: STARS Subgroup Analyses for Apraglutide in SBS-IF

Apraglutide offers a consistent benefit for patients with short bowel syndrome and intestinal failure (SBS-IF) regardless of baseline demographics and disease-specific characteristics, according to findings from a subgroup analysis of the phase 3 STARS study.

Findings were presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting in Philadelphia, Pennsylvania, by Kishore Iyer, MBBS, MSc, FRCS(Eng), FACS, director of adult and pediatric intestinal rehabilitation and transplantation at Mount Sinai. The additional analyses of STARS data revealed a consistent magnitude of treatment effect across all subgroups in the overall population.

Although Iyer indicated he did not believe there was any reason to think a specific subgroup would behave differently, he noted “there is some data that suggests patients who receive a higher volume of parenteral support at baseline are perhaps more likely to show a greater response to exogenous GLP-2 than patients receiving a low volume of parenteral support.”

However, results of the subgroup analyses indicated a consistent decrease in parenteral support, the primary endpoint in STARS, among all patients treated with apraglutide across different demographic subgroups and subgroups based on disease characteristics.

Iyer went on to describe exogenous GLP-2 as a “game changer” for the field, citing the burden faced by patients with intestinal failure and the benefit of having effective treatment options to reduce this burden.

Although teduglutide is currently commercially available for these patients, Iyer noted its administration by daily injection serves as an important limitation to its use in a patient population that already faces a major medication burden. Apraglutide, however, has the potential to offer a similar benefit when administered once weekly.

An investigational, next-generation, long-acting synthetic GLP-2 analog, apraglutide’s safety and efficacy for SBS-IF was confirmed in the phase 3 STARS trial with results showing significantly more patients treated with apraglutide gained additional days off from parenteral support per week and were clinical responders or clinical high responders. Now, additional findings from a subgroup of the STARS trial confirm apraglutide’s benefit regardless of demographics and disease characteristics.

Editors’ note: Iyer has relevant disclosures with Hanmi Pharmaceuticals, Northsea Therapeutics, Takeda Pharmaceuticals, and VectivBio (now part of Ironwood Pharmaceuticals).

Reference

^{Iyer K, Joly F, Kirby D, et al. 19 - Phase 3, Double-Blind, Randomized STARS Trial of Apraglutide Once-Weekly in Patients with Short Bowel Syndrome and Intestinal Failure (SBS-IF): Subgroup Analyses by Baseline Demographics and SBS Disease Characteristics. Presented at: American College of Gastroenterology (ACG) 2024 Scientific Sessions. Philadelphia, PA. October 25 – 30, 2024.}