• Apraglutide nutritional data from STARS Nutrition Phase 2 study in adult patients who have short bowel syndrome with intestinal failure and colon-in-continuity will be highlighted in an oral presentation
• Additional data on apraglutide from previously completed Phase 1 and Phase 2 studies will also be highlighted in poster presentations

BOSTON / Feb 23, 2024 / Business Wire / Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, announced today that the company will present findings from four studies evaluating apraglutide in adults with short bowel syndrome with intestinal failure (SBS-IF), a condition in which they are dependent on parenteral support, during the American Society for Parenteral and Enteral Nutrition (ASPEN) 2024 Nutrition Science & Practice Conference. ASPEN is being held from March 2-5, 2024, in Tampa, Florida.

SBS is a serious and chronic condition where there is diminished absorptive capacity for fluids and/or nutrients, typically resulting from extensive intestinal resection. Adult patients with SBS who are dependent on parenteral support (PS) to meet their nutritional and hydration needs, also referred to as SBS-IF, have significant quality of life impact and risk of severe complications such as infection. In these patients with SBS who are dependent on PS, the type of remnant bowel anatomy, such as colon-in-continuity or the presence of a jejunostomy or ileostomy, plays a critical role in how they respond to treatment.

The data being presented on apraglutide will include an oral presentation of fluid and energy absorption results at 4 weeks in SBS-IF with colon-in-continuity from the STARS Nutrition clinical trial, and poster presentations on apraglutide’s effect on reduction in PS needs and its safety profile in patients with SBS-IF with colon-in-continuity at one year, an epidemiological study of SBS-IF using real-world data, and an analysis of the pharmacokinetics of apraglutide in people with normal and impaired hepatic function.

“We are excited to share these findings on apraglutide with the international community of nutrition experts at ASPEN, a meeting which is singularly focused on critical nutrition support,” said Michael Shetzline, M.D., Ph.D., chief medical officer, senior vice president, and head of research and drug development at Ironwood Pharmaceuticals. “These findings continue to deepen our understanding of GLP-2 and the potential of apraglutide to help adult patients with SBS who are dependent on PS, including those with colon-in-continuity. Our hope is that if approved, apraglutide will have a positive impact on these patients.”

An estimated 18,000 adult patients in the U.S., Europe, and Japan suffer from SBS-IF, a rare and severe organ failure condition resulting from extensive intestinal resection, in which patients are dependent on PS to meet their nutritional and fluid requirements.

An overview of the presentations is below. Presentation details (abstracts, when available, can be accessed on the ASPEN 2024 meeting website at https://www.nutritioncare.org/abstracts/):

• The Novel Long-Acting Glp-2 Analog Apraglutide Improves Wet Weight Absorption in Patients with Short Bowel Syndrome with Intestinal Failure and Colon-In-Continuity
  • Oral presentation: March 3, 2:00 – 3:30 p.m. ET
• The Long-Acting GLP-2 Analog Apraglutide Reduces Parenteral Support Needs in Patients with Short Bowel Syndrome With Intestinal Failure and Colon in Continuity: 1-Year Results of a Multicenter, Open-Label, Phase 2 Trial
  • Poster presentation: March 3 and 4, 12:45 – 1:45 p.m. ET
• Epidemiology of Patients with Short Bowel Syndrome with Intestinal Failure (SBS-IF) in the US – Findings Using Real-World Data
  • Poster presentation: March 3 and 4, 12:45 – 1:45 p.m. ET
• Pharmacokinetics and Safety of Single-Dose Apraglutide in Individuals with Normal and Impaired Hepatic Function: A Phase 1, Open-Label Trial
  • Poster presentation: March 3 and 4, 12:45 – 1:45 p.m. ET

Ironwood is also sponsoring an Innovation Theater presentation entitled “Oral Nutrition in the Era of GLP-2: An Essential Factor in Maximizing Intestinal Adaptation for Patients With SBS-IF” on Sunday, March 3, from 12:45 to 1:30 p.m. ET. The presentation is chaired by Dr. Dejan Micic from the University of Chicago and will be joined by the faculty for an in-depth discussion on the importance of oral nutrition for patients with SBS-IF in the era of GLP-2 treatment.

About Short Bowel Syndrome (SBS)

SBS is a serious and chronic condition where there is diminished absorptive capacity for fluids and/or nutrients, sometimes requiring dependence on parenteral support to maintain health. Short bowel syndrome typically occurs because of extensive intestinal resection, and patients with SBS who are chronically dependent on parenteral support often experience significant quality of life impact and are at risk of severe complications such as infection. Patients with SBS with intestinal failure (SBS-IF) require PS to meet their nutritional and hydration needs, and the type of remnant bowel anatomy, such as colon-in-continuity or the presence of a jejunostomy or ileostomy, plays a critical role in how they respond to treatment.

An estimated 18,000 adult patients suffer from SBS-IF in the U.S., Europe and Japan, and have chronic dependence on PS, which significantly impacts quality of life and carries the risk of severe complications such as infection. Those with the most severe SBS-IF require PS infusions for up to 10 to 15 hours per day. SBS-IF is associated with frequent complications, significant morbidity and mortality, high economic burden and an impaired quality of life. SBS is an anatomically heterogenous condition in which the type of remnant bowel anatomy - such as presence of absence of colon-in-continuity - influences the pathophysiology and determines the degree of PS dependence, therapeutic goal, medical needs and clinical response to treatment.

About Apraglutide

Apraglutide is an investigational, next-generation, long-acting synthetic GLP-2 analog being developed for a range of rare gastrointestinal diseases where GLP-2 can play a central role in addressing disease pathophysiology, including short bowel syndrome with intestinal failure (SBS-IF) and Acute Graft-Versus-Host Disease (aGVHD).

About Ironwood Pharmaceuticals

Ironwood Pharmaceuticals (Nasdaq: IRWD), an S&P SmallCap 600® company, is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS® (linaclotide), which is the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC) and is also indicated for the treatment of functional constipation in pediatric patients ages 6-17 years old. Ironwood is also advancing apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for rare gastrointestinal diseases, including short bowel syndrome with intestinal failure (SBS-IF) as well as several earlier stage assets. Building upon our history of GI innovation, we keep patients at the heart of our R&D and commercialization efforts to reduce the burden of GI 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.

Forward-Looking Statements

This press release contains forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, including statements about the therapeutic potential of apraglutide, if approved, and the estimated population suffer from SBS-IF in the U.S., Europe and Japan. 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 preclinical and clinical development, manufacturing and formulation development of apraglutide; the risk that clinical programs and studies, including for apraglutide, 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 completed nonclinical and clinical studies may not be replicated in later studies; 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 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 efficacy, safety and tolerability of our product candidates; the risk that the commercial and therapeutic opportunities for our product candidates are not as we expect; decisions by regulatory and judicial authorities; the risk we may never get additional patent protection for our product candidates, that patents for our products may not provide adequate protection from competition, or that we are not able to successfully protect such patents; the risk that the development of apraglutide 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; challenges from and rights of competitors or potential competitors; 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, 2023, and in our subsequent Securities and Exchange Commission filings.