Sep 7, 2026
2:00 PM3:30 PM
ePoster presentations
PP396
LONG-TERM TREATMENT WITH ONCE-WEEKLY APRAGLUTIDE REDUCES PARENTERAL SUPPORT VOLUME AND INCREASES CLINICAL RESPONDER RATES IN PATIENTS WITH SHORT BOWEL SYNDROME AND INTESTINAL FAILURE
S. Lal1, D. Kirby2, K. Tappenden3, P. Jeppesen4, F. Joly5,*, C. Ming6, T. Masior6, M. Boules7, T. Vanuytsel8, K. Iyer9
1The University of Manchester, Manchester, United Kingdom, 2Cleveland Clinic, Cleveland, 3University of Utah Health, Salt Lake City, United States, 4Rigshospitalet, Copenhagen, Denmark, 5Hôpital Beaujon, Clichy, France, 6Ironwood Pharmaceuticals Inc, Basel, Switzerland, 7Ironwood Pharmaceuticals Inc, Boston, United States, 8UZ Leuven, Vlaams-Brabant, Belgium, 9Mount Sinai Health System, New York, United States
Rationale: The long-acting glucagon-like peptide-2 analog apraglutide (APRA) can reduce parenteral support (PS) requirements in patients with short bowel syndrome and intestinal failure (SBS-IF). We report long-term data on PS volume reduction from 3 clinical trials of patients with SBS-IF receiving APRA. First presented at ACG 2025, October 24–29, 2025.
Methods: Eligible patients who completed the Phase 2 STARS Nutrition (NCT04964986) or Phase 3 STARS (NCT04627025) studies could opt to continue receiving APRA (APRA/APRA) at 3.5 mg (if ≥50 kg) or 1.4 mg (if <50 kg), or switch from placebo to APRA (PBO/APRA) for up to 208 weeks in STARS Extend (NCT05018286). Data from these studies were used to evaluate changes from baseline (APRA treatment start) in weekly PS volume and proportion of clinical responders (≥20% PS volume reduction) and clinical high responders (≥40% reduction) at Weeks 52, 104, 152 and 208; and long-term safety and tolerability.
Results: As of January 2025, 166 patients (All-APRA) were analyzed (APRA/APRA, n=119; PBO/APRA, n=47). Baseline characteristics were generally balanced across groups. In the All-APRA group, reductions in weekly PS volume from baseline of 36.9% (APRA/APRA: –36.1%; PBO/APRA: –39.1%) and 47.9% (APRA/APRA: –47.8%; PBO/APRA: –48.4%) were observed at 52 and 104 weeks, respectively (Table). At Week 104, clinical responder rates (≥20% reduction) were 75.0%, 75.7% and 70.0%, and clinical high responder rates (≥40% reduction) were 57.1%, 56.8% and 60.0% in the All-APRA, APRA/APRA and PBO/APRA groups, respectively. APRA was well tolerated with long-term use.
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Conclusion: Long-term treatment with once-weekly APRA resulted in high clinical responder rates and sustained reductions in weekly PS volume from baseline through 104 weeks, with no safety concerns.
Disclosure of Interest: S. Lal Grant / Research Support from: Simon Lal has received honoraria and/or educational support from Baxter, B Braun, Fresenius Kabi, NorthSea Thereapeutics, Takeda, VectivBio (now part of Ironwood Pharmaceuticals Inc) and Zealand Pharma; and has received investigator-initiated/unrestricted research grants from Baxter, Fresenius Kabi and Takeda, D. Kirby Consultant for: Donald Kirby serves as a consultant or advisor for OWYN, Takeda Pharma and VectivBio (now part of Ironwood Pharmaceuticals Inc), K. Tappenden Other: Kelly Tappenden serves as a board member, advisory panel or speaker for Abbott Nutrition Health Institute, Nutricia North America, Takeda Pharmaceuticals and VectivBio (now part of Ironwood Pharmaceuticals, Inc), P. Jeppesen Grant / Research Support from: Palle Jeppesen has received 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 Pharmaceuticals Inc, Naia Pharmaceuticals, NPS Pharmaceuticals, Protara Therapeutics, Shire, Takeda, The Novo Nordisk Foundation, Therachon, VectivBio (now part of Ironwood Pharmaceuticals Inc) and Zealand Pharma, F. Joly Grant / Research Support from: Francisca Joly has received research funding from Baxter, Carembouche, Mobile3esolutions, Takeda Pharma, VectivBio and Zealand Pharma, Consultant for: Francisca Joly serves as a consultant or advisor for Carembouche, Hanmi, Ironwood, Mobile3esolutions, NorthSea Therapeutics, Takeda, VectivBio (now part of Ironwood Pharmaceuticals Inc) and Zealand Pharma, Other: Francisca Joly serves as a lecturer for Baxter, B Braun, Fresenius Kabi, Janssen and Theradial, C. Ming Other: Chang Ming serves as an employee of Ironwood Pharmaceuticals Inc and may hold Ironwood Pharmaceuticals Inc stock, T. Masior Other: Tomasz Masior serves as an employee of Ironwood Pharmaceuticals Inc and may hold Ironwood Pharmaceuticals Inc stock, M. Boules Other: Mena Boules serves as an employee of Ironwood Pharmaceuticals Inc and may hold Ironwood Pharmaceuticals Inc stock, T. Vanuytsel Grant / Research Support from: Tim Vanuytsel has received research grants from Danone, MyHealth, Takeda and VectivBio (now part of Ironwood Pharmaceuticals Inc), Consultant for: Tim Vanuytsel serves as a consultant for Baxter, BMS, Dr. Falk Pharma, Hanmi Pharm, NorthSea Therapeutics, Takeda, Truvion, VectivBio (now part of Ironwood Pharmaceuticals Inc) and Zealand Pharma, Other: Tim Vanuytsel serves as a lecturer for Abbott, Baxter, Biocodex, Dr. Falk Pharma, Fresenius Kabi, Ipsen, Menarini, MyHealth, Remedus, Takeda, Truvion and VectivBio (now part of Ironwood Pharmaceuticals Inc), K. Iyer Grant / Research Support from: Kishore Iyer has received grants from Takeda; serves as an advisor or has received grant support from VectivBio (now part of Ironwood Pharmaceuticals Inc) and NorthSea Therapeutics, Consultant for: Kishore Iyer serves as a consultant or advisor for Takeda, Speakers Bureau of: Kishore Iyer serves as a speaker or member of speakers bureau for Takeda, Other: Kishore Iyer serves as an advisor for Hanmi Pharmaceuticals