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

WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE   LINZESS is contraindicated in patients less than 2 years of age. In nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration.

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 <1% of 72 mcg LINZESS-treated CIC patients.
• In children and adolescents 6 to 17 years of age, diarrhea was the most common adverse reaction in 72 mcg LINZESS-treated patients in the FC double-blind placebo-controlled trial. Severe diarrhea was reported in <1% of 72 mcg LINZESS treated patients. If severe diarrhea occurs, dosing should be suspended and the patient rehydrated.

Common Adverse Reactions (incidence ≥2% and greater than placebo)

• In IBS-C or CIC adult patients: diarrhea, abdominal pain, flatulence, and abdominal distension.
• In FC pediatric patients: diarrhea.

Please see full Prescribing Information including Boxed Warning: https://www.rxabbvie.com/pdf/linzess_pi.pdf

LINZESS^® and CONSTELLA^® are registered trademarks of Ironwood Pharmaceuticals, Inc. Any other trademarks referred to in this press release are the property of their respective owners. All rights reserved.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Investors are cautioned not to place undue reliance on these forward-looking statements, including statements about Ironwood’s plan to submit an NDA and marketing applications to other regulatory filings for apraglutide and the expected timing to complete such the NDA submission; assessment from the Phase III study evaluating linaclotide in pediatric patients aged 7–17 years with IBS-C and results from a real-world study evaluating the association between pediatric functional constipation and CIC in young adults. These forward-looking statements speak only as of the date of this press release, and Ironwood undertakes no obligation to update these forward-looking statements. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include those related to the effectiveness of development and commercialization efforts by us and our partners; preclinical and clinical development, manufacturing and formulation development of linaclotide, apraglutide, IW-3300, and our other product candidates; the risk of uncertainty relating to pricing and reimbursement policies in the U.S., which, if not favorable for our products, could hinder or prevent our products’ commercial success; the risk that healthcare reform and other governmental and private payor initiatives may have an adverse effect upon or prevent our products’ or product candidates’ commercial success; the risk that apraglutide will not be approved by the FDA or other regulatory agencies; the risk that clinical programs and studies, including for linaclotide pediatric programs, apraglutide and IW-3300, may not progress or develop as anticipated, including that studies are delayed or discontinued for any reason, such as safety, tolerability, enrollment, manufacturing, economic or other reasons; the risk that findings from our ongoing and completed nonclinical studies and clinical trials may not be replicated in later trials or further data analyses and earlier-stage clinical trials may not be predictive of the results we may obtain in later-stage clinical trials or of the likelihood of regulatory approval; the risk of competition or that new products may emerge that provide different or better alternatives for treatment of the conditions that our products are approved to treat; the risk that we are unable to execute on our strategy to in-license externally developed products or product candidates; the risk that we are unable to successfully partner with other companies to develop and commercialize products or product candidates; the efficacy, safety and tolerability of linaclotide and our product candidates; the risk that the commercial and therapeutic opportunities for LINZESS, apraglutide or our other product candidates are not as we expect; decisions by regulatory and judicial authorities; the risk we may never get additional patent protection for linaclotide, apraglutide and other product candidates, that patents for linaclotide, apraglutide or other products may not provide adequate protection from competition, or that we are not able to successfully protect such patents; the risk that we are unable to manage our expenses or cash use, or are unable to commercialize our products as expected; the risk that the development of any of our linaclotide pediatric programs, apraglutide and/or IW-3300 is not successful or that any of our product candidates does not receive regulatory approval or is not successfully commercialized; outcomes in legal proceedings to protect or enforce the patents relating to our products and product candidates, including abbreviated new drug application litigation; the risk that financial and operating results may differ from our projections; developments in the intellectual property landscape; challenges from and rights of competitors or potential competitors; the risk that our planned investments do not have the anticipated effect on our company revenues; developments in accounting guidance or practice; Ironwood’s or AbbVie’s accounting practices, including reporting and settlement practices as between Ironwood and AbbVie; the risk that our indebtedness could adversely affect our financial condition or restrict our future operations; and the risks listed under the heading “Risk Factors” and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2024, and in our subsequent Securities and Exchange Commission filings.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250422158323/en/

Company:

Greg Martini

Chief Financial Officer

gmartini@ironwoodpharma.com



Investors:

Precision AQ (formerly Stern Investor Relations)

Stephanie Ascher

Stephanie.Ascher@precisionaq.com

Source: Ironwood Pharmaceuticals, Inc.

FAQ

What are the key findings from Ironwood's Phase III linaclotide study in pediatric IBS-C patients?

The Phase III study results for linaclotide in pediatric patients aged 7-17 years with IBS-C will be presented at DDW 2025. This represents the first completed Phase III study for IBS-C in this age group, with both efficacy and safety data to be discussed.

How will the new ICD-10 codes impact SBS patient care and IRWD's apraglutide development?

The new ICD-10 codes, approved in October 2023, aim to improve disease recognition, patient tracking, and access to care for SBS patients dependent on parenteral support. This standardization supports Ironwood's development of apraglutide, their next-generation GLP-2 analog treatment.

What research presentations will IRWD showcase at Digestive Disease Week 2025?

IRWD will present real-world data on SBS ICD-10 code adoption, Phase III study results of linaclotide in pediatric IBS-C patients, and research on the connection between pediatric functional constipation and chronic idiopathic constipation in young adults.

When and where will Ironwood Pharmaceuticals present their DDW 2025 research?

Ironwood will present their research at Digestive Disease Week® (DDW) from May 3-6, 2025, in San Diego, CA. Presentations include both poster sessions and oral presentations at various times throughout the conference.