Ironwood Presents New Data on Potential of Linaclotide for Functional Constipation in Children and Adolescents Ages 6-17 Years-Old at Digestive Disease Week 2023

Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, presented findings during the 2023 Digestive Disease Week (DDW) meeting from a Phase III clinical trial on the potential of linaclotide for children and adolescents ages 6-17 years-old with functional constipation. Ironwood had previously announced topline data from this study in September 2022.

The presented data at DDW, which provided a more detailed description of the trial results, were announced during an oral presentation titled Efficacy and Safety of Linaclotide in Treating Functional Constipation in Pediatric Patients Aged 6-17 Years: A Phase 3, Pivotal, Randomized, Placebo-Controlled Trial (presentation number 145), which highlighted that linaclotide 72 mcg met primary and secondary endpoints for increased frequency of spontaneous bowel movements (SBM) and improvement in stool consistency in this patient population. Linaclotide was generally well-tolerated and exhibited a safety profile consistent with a prior pediatric Phase II study in functional constipation.

Functional constipation in children is defined as a condition with hard, infrequent bowel movements that are often difficult or painful to pass². The condition affects an estimated 6 million children ages 6-17 years-old in the U.S.¹

“Functional constipation is one of the most common complaints patients bring to their pediatricians and pediatric gastroenterologists, yet we have no approved prescription therapies to offer to our young patients,” said Jeffrey S. Hyams, M.D., Head, Division of Digestive Diseases, Hepatology, and Nutrition, Connecticut Children’s Medical Center, Professor of Pediatrics, University of Connecticut School of Medicine. “These results are significant because they show the potential of linaclotide in addressing bothersome symptoms for patients ages 6-17 years-old with this condition.”

In this pivotal study, linaclotide showed a statistically significant and clinically meaningful improvement compared to placebo in 12-week SBM frequency rate (SBMs/week), the primary endpoint. Linaclotide-treated patients demonstrated a greater than two-fold least squares mean change from baseline in SBMs/week (2.220) compared to placebo (1.050) (p<0.0001). Stool consistency, as assessed by Bristol Stool Form Scale (BSFS) scores, which was the secondary endpoint, also showed an improvement at weeks 12 with linaclotide compared to placebo. The BSFS is a 7-point scale ranging from 1 (separate, hard, difficult-to-pass lumps) to 7 (liquid stools). Overall, linaclotide was well-tolerated in this study.