Ironwood Announces Publication in The Lancet Gastroenterology & Hepatology of New Linaclotide Phase III Data in Children and Adolescents Aged 6-17 Years with Functional Constipation

Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today announced that new data from the Phase III study that evaluated linaclotide in children and adolescents aged 6-17 years with functional constipation were published in The Lancet Gastroenterology & Hepatology. The data highlights additional efficacy endpoints from the company’s pivotal Phase III trial, which formed the basis of the June 2023 U.S. Food and Drug Administration (FDA) approval of linaclotide for the treatment of functional constipation in this population.

Functional constipation in children is defined as a condition with hard, infrequent bowel movements that are often difficult or painful to pass¹. The condition affects an estimated 6 million children aged 6-17 years in the U.S.²

“Functional constipation is among the most common complaints pediatricians and pediatric GIs see in our patients,” said Miguel Saps, Chief of Division of Pediatric Gastroenterology, Hepatology, and Nutrition and the George E. Batchelor Endowed Chair in Pediatrics, University of Miami, University of Miami Health System. “The insights provided by the additional efficacy endpoints in this Phase III clinical trial are an important supplement to clinicians’ knowledge about the available treatment options for this population.”

In this peer-reviewed pivotal study, a total of 328 patients received the study treatment, randomized (1:1) to either linaclotide 72 mcg or placebo. Linaclotide demonstrated a statistically significant and clinically meaningful improvement compared to placebo in 12-week spontaneous bowel movement(s) (SBM) frequency rate (SBMs/week), the primary endpoint. A statistically significant proportion of linaclotide-treated patients achieved 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 week 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). The change from baseline of 12-week complete SBM frequency rate demonstrated a greater increase in the linaclotide group compared with the placebo group (LSM CFB difference=0.96 complete SBMs/week; 95% CI 0.51–1.40; p<0.0001). Additionally, the percentage of patients with at least one SBM within 24 or 48 hours of first dose of study drug was higher in the linaclotide group compared with the placebo group (24 hours: 30.5% vs 20.7%, p=0.043; 48 hours: 56.7% vs 38.4%, p=0.0009).