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EFFICACY AND SAFETY OF APRAGLUTIDE ONCE-WEEKLY IN PATIENTS WITH SHORT BOWEL SYNDROME AND INTESTINAL FAILURE (SBS-IF): RESULTS FROM THE STARS STUDY – A GLOBAL PHASE 3 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL

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EFFICACY AND SAFETY OF APRAGLUTIDE ONCE-WEEKLY IN PATIENTS WITH SHORT BOWEL SYNDROME AND INTESTINAL FAILURE (SBS-IF): RESULTS FROM THE STARS STUDY – A GLOBAL PHASE 3 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL

Francisca Joly 1, Tim Vanuytsel 2, Donald Kirby 3, Simon Lal 4, Kelly Tappenden 5, Palle Bekker Jeppesen 6, Nader N. Youssef 7, Carrie Li 7, Reda Sheik 7, Isabelle Statovci 7, Susanna Huh 8, Federico Bolognani 7, Kishore Iyer 9

Affiliations

1 Beaujon Hospital Service de Gastroenterologie, Clichy, France

2 KU Leuven, Leuven, Belgium

3 Cleveland Clinic, Cleveland, United States

4 University of Manchester, Manchester, United Kingdom

5 The University of Utah, Salt Lake City, United States

6 Rigshospitalet, Copenhagen, Denmark

7 Ironwood Pharmaceuticals, Basel, Switzerland

8 Ironwood Pharmaceuticals, Boston, United States

9 Mount Sinai Medical Center, New York, United States

Summary

AI Generated

Apraglutide, a once-weekly GLP-2 analogue, significantly reduced parenteral support volume by 25.5% versus 12.5% with placebo at 24 weeks in adults with short bowel syndrome and intestinal failure (p=0.001).

The primary endpoint was met with a mean 13.0% greater reduction in weekly parenteral support volume at Week 24 compared to placebo, with treatment effect observed from Week 8 onward.
A significantly higher proportion of apraglutide-treated patients achieved at least one additional day per week off parenteral support at Week 24 (43.0% vs 27.5%, p=0.040).
In the stoma subgroup, apraglutide reduced weekly parenteral support volume by 25.6% versus 7.8% with placebo (p<0.001), while the colon-in-continuity subgroup showed a numerical but non-significant benefit (25.2% vs 17.6%, p=0.179).
Clinical responders, defined as patients with at least 20% parenteral support reduction at both Weeks 20 and 24, were more frequent with apraglutide (42.7% vs 20.8%, p=0.003).
Only 3.6% of apraglutide-treated patients discontinued due to an adverse event versus 1.9% with placebo, with a safety profile consistent with prior apraglutide studies in short bowel syndrome.

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Abstract

Introduction

In SBS-IF, patients (pts) depend on parenteral support (PS) to meet nutritional and/or fluid requirements. Apraglutide (APRA) is a long-acting novel GLP-2 analogue dosed once-weekly that stimulates intestinal adaptation, with the potential to reduce PS requirements. This phase 3 trial assessed the efficacy and safety of APRA vs placebo (PBO) in adult pts with SBS-IF.

Aims & Methods

In this phase 3 double-blind, PBO-controlled trial (NCT04627025) conducted in 73 centres and 18 countries, 164 pts were randomized 2:1 to once-weekly subcutaneous APRA (5 mg if pt ≥50 kg, 2.5 mg if pt <50 kg) or PBO, stratified by intestinal anatomy (stoma or colon-in-continuity [CIC]). The primary endpoint was relative change from baseline (BL) in weekly PS volume at Week (Wk) 24. Key secondary endpoints at Wk 24 were reduction of additional ≥1 day/Wk off PS from BL, and in the stoma subgroup, relative change from BL in weekly PS volume. Two other key secondary endpoints at Wk 48 in the CIC subgroup were reduction of ≥1 day/Wk off PS, and percentage of pts reaching total enteral autonomy. Wk 24 clinical responders were defined as proportion of pts with ≥20% PS reduction at Wks 20 and 24. Adverse events (AEs) were collected.

Results

A total of 163 dosed pts (80 stoma; 83 CIC),155 (95%) completed the study. BL demographics and mean BL weekly PS volume (APRA 13.1 L; PBO 12.9 L) were similar in both arms. At Wk 24, APRA-treated pts had a significantly larger reduction from BL in weekly PS volume vs PBO (APRA -25.5%; PBO -12.5%; p=0.001); both stoma and CIC subgroups demonstrated comparable treatment effects. In pts with stoma, the relative reduction from BL to Wk 24 in weekly PS volume in APRA pts vs PBO was statistically significant (-25.6% vs -7.8%; p<0.001) (Table 1). In pts with CIC, there was a numerical benefit in APRA that did not reach statistical significance (APRA -25.2%; PBO -17.6%; nominal p=0.179). In the overall population, statistically significant PS reductions from BL were seen from Wk 8 onward. A significantly higher proportion of APRA pts achieved a reduction of ≥1 day/Wk off PS at Wk 24 (APRA 43.0%; PBO 27.5%; p=0.040). At Wk 48 in the CIC subgroup, 51.8% of APRA vs 44.4% of PBO-treated pts achieved ≥1 day/wk off PS (p=0.348), and enteral autonomy was reached in 7 of 56 (12.5%) APRA vs 2 of 27 (7.4%). APRA was well tolerated. Of 110 APRA-treated pts, only 4 (3.6%) discontinued APRA due to an AE, vs 1 of 53 (1.9%) PBO-treated pts.

Conclusion

APRA is the first once-weekly GLP-2 analogue to demonstrate efficacy in a phase 3 trial in SBS-IF. At Wk 24, APRA demonstrated significantly greater relative reductions in weekly PS volume from BL and a higher proportion of pts achieved an additional ≥1 day off PS, with comparable treatment effects in pts with stoma or CIC. APRA showed a favourable safety profile consistent with prior APRA studies in SBS-IF.

n for the first key secondary is observed value and the percentage, difference in percentages and its p-value is based on results of multiple imputations. *nominal p-value. APRA, apraglutide; BL, baseline; CI, confidence interval; LSM, least square mean; PBO, placebo; PS, parenteral support; SBS-IF, short bowel syndrome and intestinal failure.
Endpoint	Population	Apraglutide (n=110)	Placebo (n=53)	APRA vs PBO Difference [LSM or % (95% CI)]	p-value
Primary Endpoint		LSM or n (%)
Relative % change from BL in actual PS weekly volume at Wk 24, Least Square Mean (LSM)	Overall	-25.5	-12.5	-13.0 (-20.9, -5.0)	0.001
Key Secondary Endpoints
Percentage of subjects achieving a reduction of ≥1 day/wk off PS from BL at Wk 24, n (%) *	Overall	46 (43.0)	14 (27.5)	15.6 (0.7, 30.5)	0.040
Relative % change from BL in actual PS weekly volume at Wk 24, mean	Stoma (n=80)	-25.6	-7.8	-17.8 (-28.4, -7.3)	<0.001
Percentage of subjects achieving a reduction of ≥1 day/wk off PS from BL at Wk 48, n (%)	CIC (n=83)	29/56 (51.8)	12/27 (44.4)	7.3 (-16.4, 29.8)	0.348
Subjects reaching enteral autonomy at Wk 48, n (%)	CIC (n=83)	7/56 (12.5)	2/27 (7.4)	5.1 (-12.9, 18.5)	0.387
Other Secondary Endpoint Clinical responders at Week 24 (≥20% PS reduction at both Wks 20 and 24), n (%)	Overall	47 (42.7)	11 (20.8)	22.0 (7.7, 36.2)	0.003**

Disclosure

FJ: Research funding from Takeda Pharma, VectivBio, Zealand, Baxter, Mobile3esolutions, Carembouche Consultant or advisor for Takeda, VectivBio, Ironwood; NorthSea Therapeutics, Hamni, Zealand, Mobile3esolutions, Carembouche. Lecturer for Baxter, BBraun, Fresenius Kabi, Janssen, Theradial; TV: Research Grants for Danone, MyHealth, Takeda, VectivBio. Consultancy for Baxter, BMS, Dr. Falk Pharma, Hanmi Pharm, North Sea Therapeutics, Takeda, Truvion, VectivBio, Zealand Pharma. Lecturer for Abbott, Baxter, Biocodex, Dr. Falk Pharma, Fresenius Kabi, Ipsen, Menarini, MyHealth, Remedus, Takeda, Truvion, VectivBio. DK: Consultant or advisor forTakeda Pharma, VectivBio, OWYN; SL: Investigator-initiated/unrestricted research grants from Fresenius Kabi, Baxter and Takeda. Honoraria and/or educational support from Takeda, Zealand, VectivBio, Fresenius Kabi, B Braun, Baxter, Northsea. KT: Board Member/Advisory Panel/Speaker for Abbott Nutrition Health Institute, Nutricia North America,Takeda Pharmaceuticals, VectivBio – now part of Ironwood Pharmaceuticals, Inc; PJ: Honoraria, educational and/or grants from Albumedix A/S, ArTara Therapeutics, Bainan Biotech, Baxter, Coloplast A/S, Ferring Pharmaceuticals, Fresenius Kabi, GlyPharma Therapeutic, Hanmi Pharmaceuticals, Ironwood, Naia Pharmaceuticals, NPS Pharmaceuticals, Protara Therapeutics, Shire, Takeda, The Novo Nordisk Foundation, Therachon, VectivBio AG, Zealand Pharma A/S; NNY, CL, RS, IS, SH: Ironwood employees; FB: Ironwood consultant; KI: Grant support from Takeda Pharma, VectivBio, NorthSea Therapeutics. Consultant or advisor for Takeda Pharma, VectivBio, Northsea Therapeutics, Hanmi Pharmaceuticals. Speaker or member of speakers bureau for Takeda Pharma.

Event

UEG Week Vienna 2024

Topics

Mechanisms & Personalised Medicine Neurogastroenterology & Motility Radiology & Imaging Small Intestine & Nutrition

Submission format

Abstract

Session

Short bowel syndrome

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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1 Rouen University Hospital, INSERM U1073, CIC-CRB-1404, Rouen, France

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Abstract

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UEG Week Berlin 2025

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Neurogastroenterology & Motility Small Intestine & Nutrition Primary Care

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Disorders of gut‐brain interaction: Dietary restrictions

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United European Gastroenterology Journal 2025; 13 (Supplement 8)

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Konrad Aden 1, Daniel Keszthelyi 2

Affiliations

1 IKMB + First Medical Department, Kiel, Germany

2 Maastricht University Medical Center, Maastricht, Netherlands

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UEG Week Berlin 2025

Session

Disease primer: Microbiome in diagnosis and treatment of GI disorders

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United European Gastroenterology Journal 2025; 13 (Supplement 8)

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Tamara Matysiak-Budnik 1

Affiliations

1 CHU de Nantes IMAD, Nantes, France

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Abstract

Event

UEG Week Berlin 2025

Topics

Digestive Oncology Hepatobiliary Immunology Mechanisms & Personalised Medicine Small Intestine & Nutrition

Session

The art of making clinical research precise: What will be new in therapy in 2030?

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United European Gastroenterology Journal 2025; 13 (Supplement 8)

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IMPROVEMENT IN INTESTINAL IMMUNE ACTIVATION, PERMEABILITY AND SENSITIVITY WITH LOCAL BUDESONIDE IN A VALIDATED MODEL FOR DISORDERS OF GUT-BRAIN INTERACTION

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IMPROVEMENT IN INTESTINAL IMMUNE ACTIVATION, PERMEABILITY AND SENSITIVITY WITH LOCAL BUDESONIDE IN A VALIDATED MODEL FOR DISORDERS OF GUT-BRAIN INTERACTION

Pauline Huyghe 1, Alison Accarie 1, Mathieu Meleine 1, Karen Van den Houte 1, Joran Toth 1, Lucas Wauters 2, Jan Tack 2, Ricard Farré 1, Tim Vanuytsel 2

Affiliations

1 KU Leuven, Leuven, Belgium

2 University of Leuven, University Hospital Gasthuisberg, Leuven, Belgium|||KU Leuven, Leuven, Belgium

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Abstract

Introduction

Disorders of gut-brain interaction (DGBIs), such as functional dyspepsia and irritable bowel syndrome, are chronic gastrointestinal disorders with recurrent and bothersome abdominal symptoms. Although incompletely understood, immune activation, particularly involving eosinophils and mast cells, and visceral hypersensitivity have been implicated in their pathophysiology.

Aims & Methods

Using the normoglycemic Biobreeding diabetes-prone (BBDP-N) rat, we aim to 1) characterise the immune activation in jejunal and colonic mucosa and to 2) study the effect of budesonide, a local anti-inflammatory corticosteroid, on gut physiology and sensitivity.
90-day-old BBDP-N and Biobreeding diabetes-resistant (control) rats underwent a 28-day treatment with budesonide (0.5 mg/kg/day) or vehicle. Eosinophils and mast cells were identified by staining jejunal and colonic sections with Chromotrope 2R and anti-mast cell protease 2 antibody, respectively. To assess their activity, eosinophil peroxidase (EPO) and β-hexosaminidase levels were measured. Jejunal and colonic segments were mounted in modified Ussing chambers, and permeability was assessed by the transmucosal passage of a fluorescently labelled 20 and 4kDa dextran molecule (FITC-Dx4/20), and the transepithelial electrical resistance (TEER). Sensitivity to isobaric colorectal distension was assessed(1): the ∆ area under the curve (AUC) of the visceromotor response (VMR) to wall tension was calculated at baseline and after treatment. Depending on the normality of the data, an unpaired t-test or Mann-Whitney test was performed.

Results

Comparing vehicle-treated groups, the BBDP-N rats had higher numbers of jejunal eosinophils (1366.0±201.3 vs. 561.7±55.3 eosinophils/mm²; p<0.01) and mast cells (1151.0±136.7 vs. 549.1±44.8 mast cells/mm²; p<0.001), whereas only colonic eosinophil numbers were higher (222.7±40.4 vs. 128.9±14.5 eosinophils/mm²; p=0.03). Additionally, EPO levels were higher in the BBDP-N rats in both regions (jejunum: 59.4±9.8 vs. 4.4±3.0 µg/g tissue; p<0.01 & colon: 82.0±23.6 vs. 1.6±1.1 µg/g tissue; p<0.01), with no difference in mast cell activation. Following budesonide treatment, eosinophil (jejunum, BBDP-N: 167.3±53.6 vs. 1366.0±201.3 eosinophils/mm²; p<0.001 & control: 220.1±43.7 vs. 561.7±55.3 eosinophils/mm²; p<0.01, colon: BBDP-N: 58.2±11.9 vs. 222.7±40.4 eosinophils/mm²; p<0.01 & control: 78.1±14.4 vs. 128.9±14.5 eosinophils/mm²; p=0.01) and mast cell (jejunum: BBDP-N: 418.8±51.0 vs. 1151.0±136.7 mast cells/mm²; p<0.001 & control: 305.4±67.6 vs. 549.1±44.8 mast cells/mm²; p=0.01, colon: BBDP-N: 146.5±19.1 vs. 262.6±37.5 mast cells/mm²; p<0.01 & control: 137.4±17.8 vs. 244.9±29.4 mast cells/mm²; p<0.01) levels decreased in both groups in both regions. Colonic eosinophil activation was also reduced in BBDP-N rats (21.5±9.7 vs. 82.0±23.6 µg/g tissue; p=0.05), with no effect on mast cell activation. Jejunal permeability, assessed by 20kDa passage was increased in vehicle-treated BBDP-N rats (258.0±51.5 vs. 132.0±25.1 pmol/cm²; p=0.03). Budesonide treatment significantly increased colonic TEER in BBDP-N rats (73.2±4.3 vs. 38.3±4.1 Ω.cm²; p<0.001). Colonic sensitivity to distention was significantly reduced in BBDP-N following the treatment (-20.1±17.2 vs. 207.0±85.5 mV/s x mmHg.cm; p=0.02).

Conclusion

In conclusion, our work shows the importance of eosinophil and mast cell predominant immune activation in visceral hypersensitivity in a well-characterised preclinical model of DGBI. Anti-inflammatory treatments should be re-evaluated in DGBI with intestinal eosinophil and mast cell infiltration.

References

1: Meleine M et al. Neurogastroenterology and motility, 2019.

Event

UEG Week Berlin 2025

Topics

Immunology Neurogastroenterology & Motility Small Intestine & Nutrition Oesophagus Stomach & H. Pylori

Submission format

Abstract

Session

Complexity and diversity in upper GI

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Therapeutic approach to DGBI: Drugs or diet?

Magnus Simrén 1

Affiliations

1 Sahlgrenska University Hospital - Dept of Internal Medicine, Sahlgrenska University Hospital ; Gothe, Gothenburg, Sweden

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Abstract

Event

UEG Week Berlin 2025

Topics

Neurogastroenterology & Motility Small Intestine & Nutrition Primary Care

Session

Disorders of gut‐brain interaction: Dietary restrictions

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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FERMENTABLE FIBER INTAKE AND REDUCED CROHN’S DISEASE RISK: INSIGHTS FROM THE GEM PROSPECTIVE COHORT

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FERMENTABLE FIBER INTAKE AND REDUCED CROHN’S DISEASE RISK: INSIGHTS FROM THE GEM PROSPECTIVE COHORT

Mingyue Xue 1, Catherine Mcshane 2, Kim Jeongseok 2, Haim Leibovitzh 3, Jingcheng Shao 2, Qilong Li 2, Karen Madsen 4, Reihane Khorasaniha 2, Anne Griffiths 5, Thomas D Walters 5, Allan Hillary Steinhart 1, Mark S. Silverberg 2, Levinus Dieleman 6, Hien Huynh 6, Remo Panaccione 7, Paul Beck 7, Guy Aumais 8, Iwona Wrobel 7, Alain Bitton 9, John K. Marshall 10, Charles N. Bernstein 11, Jeffrey Hyams 12, Paul Moayyedi 13, Sun-Ho Lee 2, Heather Armstrong 6, Ken Croitoru 14, Williams Turpin 2

Affiliations

1 Mount Sinai Hospital Dept. of Medicine, Toronto, Canada

2 Mount Sinai Hospital, Toronto, Canada

3 Mount-Sinai Hospital, Toronto, Toronto, Canada

4 University of Alberta, Alberta, Canada

5 Hospital for Sick Children, Toronto, Canada

6 University of Alberta Division of Gastroenterology Dept. of Medicine, Edmonton, Canada

7 University of Calgary, Calgary, Canada

8 University of Montreal / Maisonneuve Hospital, Montreal, QC, Canada

9 Royal Victoria Hospital Dept. of Gastroenterology, Montreal, Canada

10 McMaster University, Burlington, Canada

11 University of Manitoba, Winnipeg, Canada

12 CT Children's, Hartford, United States

13 McMaster University Dept. of Medicine Dept. of Gastroenterology - McMaster University Dept. of Medic, Hamilton, Canada

14 Mt Sinai Hospital, Toronto, Canada

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Abstract

Introduction

The cause of Crohn’s Disease (CD) remains unclear; however evidence suggests that dietary factors play a key role. With a rising incidence and no definitive cure, identifying modifiable risk factors is critical in preventing CD development. We aimed to study the association between fermentable dietary fibre intake and the future development of CD in an at-risk population.

Aims & Methods

Participants were recruited as part of the Crohn’s and Colitis Canada GEM study, a prospective cohort study of healthy first-degree relatives of patients with CD. At enrolment, a validated food frequency questionnaire was administered. Pectin, β-glucan, inulin, fructooligosaccharides (FOS), and arabinoxylan intake were quantified, and values energy-adjusted. Survival analysis was used to test the association between intake of fibre subtypes and risk of CD development. Generalized estimating equation tested the association between fibre intake and baseline impaired intestinal permeability (fractional urinary excretion of lactulose to mannitol ratio (LMR) >0.025); subclinical gut inflammation (faecal calprotectin (FCP) >250 μg/g); and faecal microbiome composition via 16s rRNA sequencing.

Results

76 of the 2,659 participants developed CD with a median follow-up of 8.9 years (IQR=5.7-12.3). Median age at recruitment was 17 years (IQR=12-25). 47% were male. Higher intake of inulin (HR = 0.78; 95% CI=0.61–0.99; p=0.04) and β-glucan (HR = 0.78; 95% CI=0.61–0.99; p=0.04) were associated with a reduced risk of CD development. No fibre subtype was associated with a higher risk of CD development. Lower intake of pectin, inulin, FOS and β-glucan was associated with impaired intestinal permeability (0.005<p<0.04). Lower inulin intake was associated with high FCP levels (p = 0.046). Higher pectin intake was associated with increased alpha diversity of faecal microbiome (p = 0.028). Higher inulin, FOS and pectin intake was associated with a shift in microbial taxa previously shown to be protective against CD onset in the GEM cohort; a reduction in Ruminococcus torques and an increase in NK4A214 group (phylum Firmicutes) presence (3.25×10⁻¹⁰<q<0.04).

Conclusion

This study demonstrates that dietary intake of fermentable fibre subtypes is associated with a reduced risk of CD development as well as with pleiotropic changes in CD risk biomarkers including microbiome, intestinal permeability, and subclinical inflammation. This suggests that the potential benefit of fermentable fibres on CD risk may involve changes in barrier function, and microbiome composition and function. Targeted interventions based on these findings could prove effective in preventing the onset of CD.

Event

UEG Week Berlin 2025

Topics

IBD Mechanisms & Personalised Medicine Small Intestine & Nutrition Radiology & Imaging

Submission format

Abstract

Session

IBD: What about the environment?

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

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2025

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UEG's educational platform for gastroenterology education bringing recordings, courses, guidelines, and more together in one place.

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