Ironwood Pharmaceuticals to Present Real-World Data at Digestive Disease Week® 2025 on Adoption of New Diagnosis Codes Among Short Bowel Syndrome Patients Who Are Dependent on Parenteral Support

– Additional presentations will highlight results from Phase III study evaluating linaclotide in pediatric patients aged 7-17 years with irritable bowel syndrome with constipation (IBS-C); first completed Phase III study in this patient population –

BOSTON--(BUSINESS WIRE)-- Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD) a biotechnology company developing and commercializing life-changing therapies for people living with gastrointestinal (GI) and rare diseases, announced today that the company will present real-world data during the 2025 Digestive Disease Week® (DDW) meeting, taking place May 3-6 in San Diego, CA. These data will focus on the adoption and utilization of recently approved ICD-10 (International Statistical Classification of Diseases, 10th Revision) codes among short bowel syndrome (SBS) patients dependent on parenteral support.

ICD-10 is a standardized system for classifying and coding diagnoses and symptoms, providing a common language for healthcare providers, researchers and payers. The Centers for Medicare and Medicaid Services (CMS) approved ICD-10 codes specific to SBS in October 2023, marking a significant step toward improving disease recognition, patient tracking and access to care.

Ironwood is developing apraglutide, a next-generation, long-acting synthetic GLP-2 analog, for the treatment of SBS patients who are dependent on parenteral support.

“Rare diseases often face challenges in ICD-10 coding, whether due to lack of a dedicated code, delayed implementation, or slow adoption in clinical practice, creating huge challenges across many areas and impacting diagnosis, patient care and research,” said Michael Shetzline, M.D., Ph.D., chief medical officer, senior vice president and head of research and drug development at Ironwood Pharmaceuticals. “Given our ongoing development of apraglutide, we were keen to assess how these newly approved codes are being used in real-world settings for SBS patients who are dependent on parenteral support. We look forward to sharing our findings with the broader GI and rare disease community at DDW.”

In addition to the ICD-10 analysis, Ironwood will present key findings at DDW from its Phase III study evaluating linaclotide in pediatric patients aged 7–17 years with IBS-C, which is the first completed Phase III study in IBS-C in this age group. The company will also share results from a real-world study evaluating the association between pediatric functional constipation and chronic idiopathic constipation (CIC) in young adults.

A list of the presentations is below.

Short Bowel Syndrome

• “A Real-World Analysis of Recently Approved Short Bowel Syndrome (SBS) ICD-10 Codes: Adoption and Utilization Among SBS Patients Dependent on Parenteral Support in the USA” (Abstract #4249386: May 6, 3:30 – 4:30 pm EDT) will be presented by Kishore Iyer, M.D., MBBS, FRCS, FACS, Mount Sinai Medical Center, New York, NY.

IBS-C and CIC

• “Long-Term Safety of Linaclotide in Treating Pediatric Patients Aged 7–17 Years with Irritable Bowel Syndrome with Constipation (IBS-C): Interim Results from a Phase 3 Study” (Abstract #Sa2099: May 3, 3:30 – 4:30 pm EDT) will be presented by Miguel Saps, M.D., University of Miami Health System, Miami, FL.
• “Transitions of Care: Evaluating the Association Between Pediatric Functional Constipation and Chronic Idiopathic Constipation in Young Adults” (Abstract #Sa2098: May 3, 3:30 – 4:30 pm EDT) will be presented by Neha R. Santucci, M.D., MBBS, Cincinnati Children’s, Cincinnati, OH.
• “Efficacy and Safety of Linaclotide in Treating Pediatric Patients Aged 7–17 Years with Irritable Bowel Syndrome with Constipation (IBS-C): Results From a Phase 3 Study” (Abstract #Sa624: May 5, 11:36 am EDT) will be presented by Jeffrey S. Hyams, M.D., Connecticut Children’s, Hartford, CT.

About Ironwood Pharmaceuticals

Ironwood Pharmaceuticals (Nasdaq: IRWD) is a biotechnology company developing and commercializing life-changing therapies for people living with gastrointestinal (GI) and rare diseases. Ironwood is advancing apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for short bowel syndrome patients who are dependent on parenteral support. In addition, Ironwood has been a pioneer in the development of LINZESS® (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). LINZESS is also approved for the treatment of functional constipation in pediatric patients ages 6-17 years old. Building upon our history of innovation, we keep patients at the heart of our R&D and commercialization efforts to reduce the burden of diseases and address significant unmet needs.

Founded in 1998, Ironwood Pharmaceuticals is headquartered in Boston, Massachusetts, with a site in Basel, Switzerland.

We routinely post information that may be important to investors on our website at www.ironwoodpharma.com. In addition, follow us on X and on LinkedIn.

About LINZESS® (linaclotide)

LINZESS® is the #1 prescribed brand in the U.S. for the treatment of adult patients with irritable bowel syndrome with constipation (“IBS-C”) or chronic idiopathic constipation (“CIC”), based on IQVIA data.

LINZESS is a once-daily capsule that helps relieve the abdominal pain, constipation, and overall abdominal symptoms of bloating, discomfort and pain associated with IBS-C, as well as the constipation, infrequent stools, hard stools, straining, and incomplete evacuation associated with CIC. LINZESS relieves constipation in children and adolescents aged 6 to 17 years with functional constipation. The recommended dose is 290 mcg for IBS-C patients and 145 mcg for CIC patients, with a 72 mcg dose approved for use in CIC depending on individual patient presentation or tolerability. In children with functional constipation aged 6 to 17 years, the recommended dose is 72 mcg.

LINZESS is not a laxative; it is the first medicine approved by the FDA in a class called GC-C agonists. LINZESS contains a peptide called linaclotide that activates the GC-C receptor in the intestine. Activation of GC-C is thought to result in increased intestinal fluid secretion and accelerated transit and a decrease in the activity of pain-sensing nerves in the intestine. The clinical relevance of the effect on pain fibers, which is based on nonclinical studies, has not been established.

In the United States, Ironwood and AbbVie co-develop and co-commercialize LINZESS for the treatment of adults with IBS-C or CIC. In Europe, AbbVie markets linaclotide under the brand name CONSTELLA® for the treatment of adults with moderate to severe IBS-C. In Japan, Ironwood's partner, Astellas, markets linaclotide under the brand name LINZESS for the treatment of adults with IBS-C or CIC. Ironwood also has partnered with AstraZeneca for development and commercialization of LINZESS in China, and with AbbVie for development and commercialization of linaclotide in all other territories worldwide.

LINZESS Important Safety Information

INDICATIONS AND USAGE

LINZESS® (linaclotide) is indicated for the treatment of both irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in adults and functional constipation (FC) in children and adolescents 6 to 17 years of age. It is not known if LINZESS is safe and effective in children with FC less than 6 years of age or in children with IBS-C less than 18 years of age.

IMPORTANT SAFETY INFORMATION

Contraindications

• LINZESS is contraindicated in patients less than 2 years of age due to the risk of serious dehydration.
• LINZESS is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.

Warnings and Precautions

• LINZESS is contraindicated in patients less than 2 years of age. In neonatal mice, linaclotide increased fluid secretion as a consequence of age-dependent elevated guanylate cyclase (GC-C) agonism, which was associated with increased mortality within the first 24 hours due to dehydration. There was no age dependent trend in GC-C intestinal expression in a clinical study of children 2 to less than 18 years of age; however, there are insufficient data available on GC-C intestinal expression in children less than 2 years of age to assess the risk of developing diarrhea and its potentially serious consequences in these patients.

Diarrhea

• In adults, diarrhea was the most common adverse reaction in LINZESS-treated patients in the pooled IBS-C and CIC double-blind placebo-controlled trials. The incidence of diarrhea was similar in the IBS-C and CIC populations. Severe diarrhea was reported in 2% of 145 mcg and 290 mcg LINZESS-treated patients and in