Surveyed HCPs emphasized the importance of reducing patient dependence on TPN to improve quality of life, reduce line infections and lower the risk of thrombosis. The majority (46.4%) identified reducing the number of days per week on TPN as a priority attribute of future therapies. An additional 30.1% prioritized reducing TPN hours per day, while fewer respondents (11.3%) prioritized reducing TPN volume.

SBS is a serious and chronic condition characterized by reduced absorptive capacity for fluids and/or nutrients, often requiring long-term dependence on parenteral support or PS (IV nutrition and/or IV hydration) to sustain life. Patients with SBS who are chronically dependent on PS, also referred to as SBS with intestinal failure (SBS-IF), frequently experience significant treatment burden, reduced quality of life and increased risk of severe complications such as infections. Despite current management approaches, substantial unmet need remains for therapies that reduce PS dependence and improve outcomes. An estimated 18,000 adult patients suffer from SBS-IF in the U.S., Europe and Japan, and have chronic dependence on PS.

"For many people living with short bowel syndrome, TPN is life-sustaining but can also profoundly affect quality of life. The LANDMARK survey shows that there remains a clear need for more therapies that further reduce TPN dependence," said Syed-Mohammed R. Jafri, M.D., a gastroenterologist and transplant hepatologist with Detroit-based Henry Ford Health and lead author of the study. "While reducing TPN volume is still important, reducing the number of days on TPN may have a more meaningful impact on patients' lives."

The survey findings also highlighted the significant burden associated with long-term TPN dependence among patients with SBS-IF. HCPs cited central line infections (59.8%), fatigue (47.9%), central line pain (43.2%), abdominal pain (40.5%), edema (37.5%) and thrombosis (29.5%) as the most common complications. Central line infections (49.7%) and central line pain (44.0%) were identified as the most distressing issues for patients. Nearly half of respondents (48.2%) cited central venous catheter related challenges – including infections, pain and thrombosis – as a primary limitation of TPN, followed by decreased quality of life (34.8%) and hepatotoxicity (32.4%).

"The survey findings underscore the real-world experience of patients suffering with SBS-IF while the endpoints in our STARS and STARS-2 clinical trials of apraglutide are designed to evaluate dimensions of parenteral support dependence, including reduction in TPN volume and increases in days off TPN," said Michael Shetzline, M.D., Ph.D., chief medical officer, senior vice president and head of research and drug development at Ironwood Pharmaceuticals. "By staying grounded in real-world insights from HCPs – and patients – we can better focus on improving patient outcomes."

In addition to the survey findings, Ironwood and its collaborators presented data from apraglutide and linaclotide studies. Key findings are summarized below.

Apraglutide Long-Term Safety Data

Data pooled from the STARS clinical program – including the Phase 2 STARS Nutrition study, STARS Phase 3 randomized placebo-controlled parent study and the ongoing open-label extension STARS Extend – demonstrated that apraglutide showed a well-tolerated long-term safety profile consistent with previous studies, low discontinuation rates due to TEAEs and no new safety observations.
Linaclotide Data

In pediatric patients aged 2-5 years with functional constipation, data from a Phase 3 open-label extension showed that linaclotide 72 mcg was well tolerated with no new safety signals. The majority of patients saw their FC symptoms resolve, with a low incidence of diarrhea.
In adults with IBS-C, a post-hoc analysis showed that linaclotide was associated with improved IBS-C symptoms across race, ethnicity and age subgroups. Safety outcomes were consistent with the established safety profile.
In adults with severe CIC, a post-hoc pooled analysis of Phase 3 studies showed that linaclotide 72 mcg or 145 mcg improved bowel movement frequency, stool consistency, straining and most abdominal symptoms, highlighting its ability to address both bowel function and symptom burden.
A post-hoc analysis showed that linaclotide demonstrated efficacy across key clinical endpoints in adults with CIC and IBS-C irrespective of pH-modifying agent use, and in IBS-C irrespective of pH-modifying agent use, with safety outcomes consistent with the known safety profile.