Ironwood Presents Survey Data at DDW 2026 Highlighting Urgent Need for Treatments Addressing the Multifaceted Burden of Total Parenteral Nutrition in Short Bowel Syndrome
Ironwood Pharmaceuticals, a biotechnology company focused on developing and commercializing therapies for gastrointestinal (GI) and rare diseases, has unveiled new data at Digestive Diseases Week 2026 highlighting healthcare provider (HCP) perspectives on the use of total parenteral nutrition (TPN) in managing short bowel syndrome (SBS). The findings, derived from a comprehensive survey, underscore a growing consensus among clinicians: reducing patients’ reliance on TPN is critical to improving quality of life and minimizing complications associated with long-term intravenous nutrition.
Short bowel syndrome is a serious and chronic condition characterized by the body’s reduced ability to absorb fluids and nutrients due to significant loss or dysfunction of the small intestine. As a result, many patients require long-term parenteral support (PS), including intravenous nutrition and hydration, to sustain life. Patients who are chronically dependent on PS are often classified as having SBS with intestinal failure (SBS-IF), a severe form of the condition associated with substantial clinical burden. Despite advances in disease management, there remains a pronounced unmet need for therapies that can reduce PS dependence while improving patient outcomes.
The survey presented by Ironwood provides valuable insight into how healthcare providers prioritize treatment goals for SBS-IF patients. Notably, 46.4% of respondents identified reducing the number of days per week that patients require TPN as the most important attribute for future therapies. This preference suggests that clinicians view fewer treatment days as having a meaningful impact on patients’ daily lives, potentially enabling greater independence and flexibility. Meanwhile, 30.1% of respondents prioritized reducing the number of hours per day spent on TPN, and a smaller proportion—11.3%—focused on reducing the overall volume of TPN administered.
These findings highlight a shift in how treatment success is defined in SBS-IF, with increasing emphasis on patient-centric outcomes rather than purely clinical measures. Reducing the frequency and duration of TPN not only lessens the logistical burden of treatment but also addresses many of the complications associated with long-term intravenous therapy.
According to Syed-Mohammed R. Jafri, a gastroenterologist and transplant hepatologist at Henry Ford Health and lead author of the survey, TPN remains both a lifeline and a significant challenge for patients. While it is essential for survival, long-term use can profoundly impact quality of life. He emphasized that the survey results demonstrate a clear need for therapies that go beyond simply sustaining patients, instead enabling them to live more normal, less medically constrained lives. In particular, reducing the number of days patients must rely on TPN may offer the greatest improvement in day-to-day well-being.
The survey also sheds light on the extensive burden associated with chronic TPN use. Healthcare providers identified a range of complications frequently experienced by SBS-IF patients, including central line infections (reported by 59.8% of respondents), fatigue (47.9%), central line pain (43.2%), abdominal pain (40.5%), edema (37.5%), and thrombosis (29.5%). Among these, central line infections and pain were considered the most distressing for patients, cited by 49.7% and 44.0% of respondents, respectively.
In addition, nearly half of the surveyed clinicians (48.2%) pointed to central venous catheter-related issues—such as infections, discomfort, and clotting—as the primary limitations of TPN therapy. Other significant concerns included diminished quality of life (34.8%) and hepatotoxicity (32.4%), further illustrating the multifaceted challenges faced by patients undergoing long-term parenteral nutrition.
Ironwood leadership emphasized that these real-world insights are instrumental in guiding the company’s research and development strategy. Michael Shetzline, chief medical officer and head of research and drug development at Ironwood, noted that understanding both clinician and patient perspectives is essential for designing therapies that address meaningful endpoints. He highlighted that the company’s ongoing clinical programs are specifically structured to evaluate reductions in parenteral support dependence, including both decreases in TPN volume and increases in the number of TPN-free days.
One of the key investigational therapies in Ironwood’s pipeline is apraglutide, a long-acting GLP-2 analog being studied for the treatment of SBS-IF. Data presented at DDW 2026 from the STARS clinical program—which includes Phase 2 and Phase 3 studies as well as an ongoing open-label extension—demonstrated that apraglutide has a favorable long-term safety profile. The pooled analysis showed that the therapy was generally well tolerated, with low rates of discontinuation due to treatment-emergent adverse events and no new safety concerns identified. These findings reinforce the potential of apraglutide as a therapeutic option aimed at reducing reliance on parenteral support.
In addition to apraglutide, Ironwood presented new data on linaclotide, a guanylate cyclase-C agonist already approved for certain gastrointestinal conditions. Multiple analyses highlighted its efficacy and safety across diverse patient populations and indications.
In pediatric patients aged 2 to 5 years with functional constipation, results from a Phase 3 open-label extension study showed that linaclotide at a 72 mcg dose was well tolerated and did not reveal any new safety signals. Most patients experienced resolution of their constipation symptoms, with a low incidence of diarrhea, supporting its potential utility in younger populations.
Among adults with irritable bowel syndrome with constipation (IBS-C), post-hoc analyses demonstrated that linaclotide improved symptoms consistently across subgroups defined by race, ethnicity, and age. Importantly, the safety profile remained aligned with previously established data, reinforcing confidence in its broad applicability.
Further analyses in adults with chronic idiopathic constipation (CIC), particularly those with severe disease, revealed that linaclotide significantly improved key clinical outcomes. These included increased bowel movement frequency, better stool consistency, reduced straining, and alleviation of abdominal symptoms. The results highlight the drug’s ability to address both functional and symptomatic aspects of constipation, making it a versatile treatment option.
Additional post-hoc findings indicated that linaclotide’s efficacy was maintained regardless of the use of pH-modifying agents, suggesting that its therapeutic benefits are robust across varying treatment conditions. Safety outcomes in these analyses were consistent with the drug’s known profile, with no unexpected adverse events observed.
Overall, the data presented by Ironwood at DDW 2026 provide a comprehensive view of both the challenges and opportunities in managing gastrointestinal disorders such as SBS-IF, IBS-C, and CIC. The survey findings emphasize the importance of reducing treatment burden and improving quality of life for patients reliant on parenteral nutrition, while the clinical data underscore the company’s commitment to advancing therapies that address these unmet needs.
As the field continues to evolve, the integration of real-world insights with clinical innovation will be crucial in shaping the next generation of treatments. Ironwood’s ongoing research efforts, particularly in reducing dependence on TPN and enhancing patient-centered outcomes, position the company at the forefront of efforts to transform care for individuals living with complex gastrointestinal conditions.
About the LANDMARK Survey
The LANDMARK disease burden survey is a cross-sectional study of HCPs, patients and caregivers assessing the real-world burden of SBS and PS dependence. The HCP survey recruited 336 participants (U.S., n=123; Europe, n=213) with two or more years of experience treating patients with SBS-IF and actively managing one or more patients. Respondents included physicians (42.0%), pharmacists (23.0%), and dietitians (18.0%), practicing primarily in gastroenterology (45.2%), clinical nutrition/nutritional support (23.5%) and internal medicine (17.3%).
About STARS and STARS-2
The STARS (STudy of ApRaglutide in SBS) pivotal Phase 3 clinical trial represents the largest Phase 3 clinical trial in SBS-IF to date.
This global, multicenter, double-blind, randomized, placebo-controlled trial evaluated the efficacy and safety of weekly subcutaneous injections of apraglutide in adult patients with SBS-IF. STARS enrolled 164 patients and dosed 163 stratified approximately 50/50 (stoma vs. colon-in-continuity), then evaluated them over 24 weeks (stoma and colon-in-continuity populations) and 48 weeks (colon-in-continuity population only). Patients were randomized 2:1 to either once weekly apraglutide or placebo.
The primary endpoint was relative change from baseline in actual weekly PS volume at week 24. Key secondary endpoints included patients who achieved a reduction from baseline of at least 1 day/week of PS at week 24 (all patients); relative change from baseline in actual weekly PS volume at week 24 (stoma population); patients who achieved a reduction from baseline of at least 1 day/week of PS at week 48 (colon-in-continuity population); and patients reaching enteral autonomy at week 48 (colon-in-continuity population). The study was conducted in 18 countries with 68 active sites.
STARS-2 is a planned confirmatory Phase 3 clinical trial of apraglutide for patients with SBS-IF. STARS-2 is planned to be a 24-week global, randomized, double-blind, placebo-controlled trial. The clinical trial will consist of a primary endpoint measuring relative change from baseline in actual weekly PS as well as additional key secondary endpoints.
About Apraglutide
Apraglutide is an investigational, next-generation, long-acting synthetic GLP-2 analog with the potential to treat a range of rare gastrointestinal diseases where GLP-2 can play a central role in addressing disease pathophysiology. Ironwood is advancing apraglutide for short bowel syndrome (“SBS”) patients dependent on parenteral support (“PS”), a severe chronic malabsorptive condition. As the first and only GLP-2 to achieve a statistically significant reduction in weekly parenteral support volume with once-weekly administration, Ironwood believes apraglutide has the potential to improve the standard of care for adult patients with SBS who are dependent on PS.
About LINZESS (Linaclotide)
LINZESS® is the #1 prescribed brand in the U.S. for the treatment of patients with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC), based on IQVIA data. LINZESS is a once-daily capsule that helps relieve the abdominal pain and constipation, associated with IBS-C in adults and pediatric patients 7 years of age and older. LINZESS has also been shown to relieve constipation, infrequent stools, hard stools, straining and incomplete evacuation associated with CIC in adult patients. LINZESS relieves constipation in children and adolescents aged 6 to 17 years with functional constipation.
LINZESS is not a laxative; it is the first medicine approved by the FDA in a class called GC-C agonists. LINZESS contains a peptide called linaclotide that activates the GC-C receptor in the intestine. Activation of GC-C is thought to result in increased intestinal fluid secretion and accelerated transit and a decrease in the activity of pain-sensing nerves in the intestine. The clinical relevance of the effect on pain fibers, which is based on nonclinical studies, has not been established.
In the United States, Ironwood and AbbVie co-develop and co-commercialize LINZESS for the treatment of adults with IBS-C or CIC. In Europe, AbbVie markets linaclotide under the brand name CONSTELLA® for the treatment of adults with moderate to severe IBS-C. In Japan, Ironwood’s partner, Astellas, markets linaclotide under the brand name LINZESS for the treatment of adults with IBS-C or CIC. Ironwood also has partnered with AstraZeneca for development and commercialization of LINZESS in China, and with AbbVie for development and commercialization of linaclotide in all other territories worldwide.
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