Apraglutide Reduces Parenteral Support Dependency in Patients With SBS-IF

Treatment with apraglutide was associated with a reduction in parenteral support dependency in patients with short bowel syndrome with intestinal failure (SBS-IF), according to results from the phase 3 STARS trial.

The double-blind, placebo-controlled STARS trial (ClinicalTrials.gov Identifier: NCT04627025) assessed the safety and efficacy of apraglutide, a long-acting synthetic glucagon-like peptide-2 (GLP-2) analog, in adult patients with SBS-IF. Study participants were randomly assigned 2:1 to receive once-weekly subcutaneous (SC) injections of apraglutide or placebo for 24 weeks (stoma and colon-in-continuity populations) or 48 weeks (colon-in-continuity population only). The primary endpoint was the relative change from baseline in actual weekly parenteral support volume at week 24.

Findings showed the study met its primary endpoint. The relative change from baseline in actual weekly parenteral support volume at week 24 was -25.5% for the apraglutide group and -12.5% for the placebo group (P =.001). 

At 24 weeks, more patients in the apraglutide group (combined population) achieved at least 1 day/week off parenteral support relative to baseline vs placebo (secondary endpoint; 43.0% vs. 27.5%; P =.040). Moreover, in the stoma population, a greater proportion of apraglutide-treated patients demonstrated improvement in relative change from baseline in actual weekly parenteral support volume vs those who received placebo (secondary endpoint; -25.6% vs. -7.8%; P <.001).

Secondary endpoints related to the colon-in-continuity group (at least 1 day/week off parenteral support vs baseline and reaching enteral autonomy at week 48) were not found to be statistically significant.

“Patients with SBS-IF bear the dual burden of a devastating condition and a complex treatment regimen that includes hours of parenteral support, which significantly impacts their quality of life and carries a risk of severe complications such as infection,” said Michael Shetzline, MD, PhD, chief medical officer, senior vice president and head of research and drug development at Ironwood Pharmaceuticals. “We believe these results demonstrate the potential for apraglutide to improve the standard of care for all adult patients with SBS dependent on parenteral support as the only GLP-2 with once-weekly administration, if approved.”

The GLP-2 analog teduglutide (Gattex^®) is currently approved by the Food and Drug Administration for SBS patients who are dependent on parenteral support. The treatment is administered as an SC injection once daily.