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

Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, announced today that the company will present findings during the 2023 Digestive Disease Week (DDW) from studies on the potential of linaclotide for children and adolescents ages 6-17 years-old with functional constipation. DDW is being held from May 6 through May 9 in Chicago, IL.

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 ages 6-17 years-old in the U.S.¹

An oral presentation will discuss data from a Phase III clinical trial that evaluated the efficacy and safety of linaclotide 72 mcg in treating functional constipation in pediatric patients ages 6-17 years old. Ironwood had previously announced topline data from this trial in September 2022. Poster presentations will highlight data on the efficacy of linaclotide in addressing bothersome functional constipation symptoms in pediatric patients ages 6-17 years old, as well as aggregate data on the safety of linaclotide in this patient population.

Linaclotide is marketed as LINZESS by Ironwood and AbbVie in the United States and is indicated for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). It is not approved for use in patients less than 18 years of age. Ironwood announced earlier this year that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the supplemental New Drug Application for LINZESS for the treatment of children and adolescents ages 6-17 years-old with functional constipation and assigned a Prescription Drug User Fee Act (PDUFA) date of June 14^th, 2023. Additional pediatric clinical trials in IBS-C and functional constipation are ongoing. There are currently no FDA -approved prescription therapies for functional constipation.

An overview of all five presentations is provided below.

Efficacy and Safety of Linaclotide in Pediatric Functional Constipation

• Efficacy and Safety of Linaclotide in Treating Functional Constipation in Pediatric Patients Aged 6-17 Years: A Phase III, Pivotal, Randomized, Placebo-Controlled Trial
  (oral presentation, presentation number 145), by Carlo Di Lorenzo, M.D., Nationwide Children’s Hospital, Columbus, OH, on Saturday, May 6, from 10:15 to 10:30 a.m. CST in room W195

Time to Response and Impact of Linaclotide on Bothersome Functional Constipation Symptoms in a Pediatric Population