STARS: Apraglutide reduces need for parenteral support in short bowel syndrome by week 24
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Key takeaways:
- Apraglutide reduced weekly dependency on parenteral support in short bowel syndrome.
- Patients who received apraglutide achieved at least one day off parenteral support per week.
Topline results from the phase 3 STARS trial showed apraglutide reduced dependency on parenteral support for adult patients with short bowel syndrome with intestinal failure at week 24, Ironwood Pharmaceuticals announced.
The company noted that apraglutide, an investigational long-acting synthetic glucagon-like peptide 2 (GLP-2) analog, was “generally well tolerated” with a safety profile consistent with prior studies.
“Reducing dependency on parenteral support and easing treatment burden are important goals for every patient with short bowel syndrome and intestinal failure (SBS-IF),” Kishore R. Iyer, MBBS, FRCS, FACS, director of adult and pediatric intestine rehabilitation and transplantation at Mount Sinai Hospital in New York and coordinating principal investigator of the trial, said in the release. “The STARS topline results are significant as this is the first successful phase 3 placebo-controlled study in SBS-IF patients with a glucagon-like peptide-2 (GLP-2) analog with once-weekly dosing.”
In the global, phase 3 STARS trial assessing the safety and efficacy of once-weekly subcutaneous apraglutide, 163 patients with SBS-IF from both stoma and colon-in-continuity populations were enrolled to receive the drug and then examined at week 24. The colon-in-continuity population was further examined at week 48.
At week 24, the trial met its primary endpoint of relative change from baseline in actual weekly parenteral support volume compared with placebo (–25.5% vs. –12.5%; P = .001). Apraglutide also demonstrated “clinically meaningful improvement” in reducing parenteral support by at least 1 day/week relative to baseline (43% vs. 27.5%; P = .04) in the combined population, the release stated.
While more treated patients in the stoma population achieved improved relative change in actual weekly parenteral support volume from baseline (–25.6% vs. –7.8%; P < .001), those in the colon-in-continuity population did not achieve secondary endpoints. Further, apraglutide was “numerically favorable but not statistically significant” compared with placebo in improving days without parenteral support (51.8% vs. 44.4%) as well as reaching enteral autonomy (12.5% vs. 7.4%).
“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,” Michael Shetzline, MD, PhD, chief medical officer, senior vice president and head of research and drug development at Ironwood Pharmaceuticals, said in the release. “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.”
Shetzline continued: “We are thankful to the patients and clinical investigators involved in the largest study of a GLP-2 analog in SBS-IF and will work with regulators on next steps with the goal of making apraglutide available to those living with this severe condition.”
The company noted it plans to submit a new drug application to the FDA, as well as other regulatory filings, for the use of once-weekly apraglutide among adult patients with SBS dependent on parenteral support.
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