Ironwood to Present Data on New Diagnosis Code Use in SBS Patients at DDW 2025
Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a biotechnology company dedicated to developing and commercializing transformative therapies for gastrointestinal (GI) and rare diseases, announced that it will present real-world data at the 2025 Digestive Disease Week® (DDW) conference, set to take place from May 3-6 in San Diego, CA. The data will focus on the adoption and utilization of the recently approved ICD-10 (International Statistical Classification of Diseases, 10th Revision) codes for short bowel syndrome (SBS) patients who rely on parenteral support.
ICD-10 is a globally recognized standardized system used for classifying and coding diseases, conditions, and symptoms. It provides a universal language that facilitates communication among healthcare providers, researchers, and payers. The system allows for the identification, tracking, and reporting of various diseases and conditions, improving patient care, disease recognition, and access to treatment. In October 2023, the Centers for Medicare and Medicaid Services (CMS) approved specific ICD-10 codes for short bowel syndrome (SBS), marking a significant milestone in the management of this complex and rare condition.
Short bowel syndrome (SBS) is a rare disorder that occurs when a person has insufficient small intestine function, often resulting in malabsorption and requiring long-term parenteral nutrition (PN) support. This condition has long posed challenges for clinicians due to its complex diagnosis and treatment regimen. The introduction of SBS-specific ICD-10 codes is expected to address these challenges by improving the visibility and tracking of the disease, enhancing the understanding of patient needs, and optimizing access to appropriate care.
In its presentation at DDW, Ironwood will share data related to the adoption and real-world utilization of these newly introduced SBS-specific ICD-10 codes. “Rare diseases like SBS often face significant obstacles in ICD-10 coding due to the absence of dedicated codes or delayed adoption in clinical practice,” explained Michael Shetzline, M.D., Ph.D., Chief Medical Officer, Senior Vice President, and Head of Research and Drug Development at Ironwood Pharmaceuticals.
“These challenges can affect diagnosis, patient care, and research. Given our ongoing development of apraglutide, we wanted to understand how these new codes are being implemented and used in real-world clinical settings for SBS patients dependent on parenteral support. We’re excited to present our findings to the broader GI and rare disease community at DDW.”
Ironwood is actively developing apraglutide, a next-generation, long-acting synthetic GLP-2 (glucagon-like peptide-2) analog, specifically for the treatment of SBS patients who are dependent on parenteral nutrition (PN) support. Apraglutide is designed to improve the intestinal function of SBS patients and reduce their dependency on parenteral nutrition, ultimately enhancing their quality of life.
The company’s presentation at DDW will include detailed insights into the implementation of the new ICD-10 codes for SBS, including real-world data that highlights how these codes are impacting clinical practice. This session, titled “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), will be delivered by Dr. Kishore Iyer of Mount Sinai Medical Center, New York, NY. The session will take place on May 6 from 3:30 pm to 4:30 pm EDT.
In addition to the SBS-related findings, Ironwood will present key data from its Phase III study evaluating linaclotide for the treatment of pediatric patients aged 7-17 years with irritable bowel syndrome with constipation (IBS-C). This study represents the first completed Phase III clinical trial of linaclotide in pediatric patients with IBS-C, a common gastrointestinal disorder that causes pain and discomfort along with constipation.
Ironwood will also present results from a real-world study exploring the association between pediatric functional constipation and chronic idiopathic constipation (CIC) in young adults. These presentations are aimed at advancing the understanding of both IBS-C and CIC in pediatric populations, further demonstrating Ironwood’s commitment to improving the lives of patients affected by GI disorders.
The upcoming DDW presentations include:
- Short Bowel Syndrome (SBS): “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), presented by Dr. Kishore Iyer from Mount Sinai Medical Center on May 6, from 3:30 pm to 4:30 pm EDT.
- 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), presented by Dr. Miguel Saps from the University of Miami Health System, on May 3, from 3:30 pm to 4:30 pm EDT.
- “Transitions of Care: Evaluating the Association Between Pediatric Functional Constipation and Chronic Idiopathic Constipation in Young Adults” (Abstract #Sa2098), presented by Dr. Neha R. Santucci from Cincinnati Children’s, on May 3, from 3:30 pm to 4:30 pm EDT.
- “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), presented by Dr. Jeffrey S. Hyams from Connecticut Children’s, on May 5, at 11:36 am EDT.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals is a biotechnology company focused on developing and commercializing therapies for people with gastrointestinal and rare diseases. The company is advancing apraglutide, a long-acting GLP-2 analog, as a potential treatment for short bowel syndrome (SBS) patients who are dependent on parenteral support. Ironwood has also pioneered LINZESS® (linaclotide), the U.S. market leader for treating adults with irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC). LINZESS is also approved for the treatment of functional constipation in pediatric patients aged 6–17 years.
Founded in 1998, Ironwood Pharmaceuticals is headquartered in Boston, Massachusetts, with an additional site in Basel, Switzerland. The company is committed to improving the quality of life for individuals suffering from GI and rare diseases by providing effective therapies that address significant unmet medical needs.
