Ironwood Releases New IBS-C and CIC Data at the American College of Gastroenterology 2023 Annual Scientific Meeting

Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a global GI-focused healthcare company, presented new data from four scientific abstracts during the American College of Gastroenterology (ACG) 2023 Annual Scientific Meeting and Postgraduate Course. These data provide further insight into the impact of linaclotide on symptoms of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC), as well as the burden of these disorders on patients.

“IBS-C and CIC are complex disorders that involve more than just constipation, and continued research into their persistent burden promotes better understanding of the multiple needs among these patients,” said Michael Shetzline, M.D., Ph.D., chief medical officer, senior vice president and head of research and drug development at Ironwood Pharmaceuticals. “The data presented at ACG peel back the many layers of these disorders’ impact. While pain is usually associated with IBS-C, it also can be experienced by those with CIC and both patient groups can be affected by anal/rectal-related adverse consequences. Ironwood is committed to understanding the impact of linaclotide on the full spectrum of symptoms in these disorders.”

Impact of Linaclotide in Patients with IBS-C and CIC

• A poster titled Effect of Menopausal Status Defined by Age on Treatment Efficacy in Women with Irritable Bowel Syndrome with Constipation: A Post Hoc Analysis of Pooled Phase 2b/3 Trials was presented by Lin Chang, M.D., David Geffen School of Medicine at UCLA, Los Angeles, CA. In this post-hoc analysis of efficacy data from Phase 2b/3 trials, a numerically higher percentage of responders were observed for abdominal pain and constipation, 30% improvement in abdominal pain, and degree of relief of IBS symptoms in patients aged >45 vs ≤45 years; adequate relief was also significantly higher in patients aged >45. Comparing treatment response within similar age groups, significant improvements were observed in patients receiving linaclotide versus placebo for every efficacy and responder endpoint assessed (all P<0.0001).
• A poster titled Linaclotide Improves Abdominal Symptoms over Placebo in Patients with Chronic Idiopathic Constipation: A Pooled Analysis was presented by Philip S. Schoenfeld, M.D., Gastroenterology Section, John D. Dingell Veterans Affairs Medical Center, Detroit, MI. The post-hoc analysis showed that at 12 weeks the patients with CIC receiving linaclotide had statistically significant decreases in change from baseline (CFB) and % CFB for abdominal pain, discomfort, and bloating compared to patients receiving placebo (all P<0.0001). Significant improvements in all three abdominal symptoms with linaclotide versus placebo were seen starting at week 1 and sustained through week 12. A significantly greater proportion of patients receiving linaclotide were responders for improvements in abdominal pain, discomfort and bloating versus those patients receiving placebo (all P≤0.001).
• A poster titled Treatment Satisfaction and Quality of Life in Patients with Irritable Bowel Syndrome with Constipation and Chronic Idiopathic Constipation was presented by Brian Lacy, Division of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, FL. The analysis of data from a large, nationwide survey of adults in the U.S. from August 2020 to December 2021 showed that participants taking prescription medications for IBS-C and CIC were more likely to be satisfied with control of bowel or abdominal symptoms than participants taking only over-the-counter medication.

Burden of IBS-C and CIC