Ironwood Pharmaceuticals to Present New Apraglutide Data in SBS-IF at Digestive Disease Week 2024

Ironwood Pharmaceuticals, Inc., a healthcare company with a focus on gastrointestinal (GI) diseases, has announced its plans to present new data on apraglutide during the 2024 Digestive Disease Week® (DDW) meeting, scheduled for May 18-21 in Washington, D.C. Apraglutide is being studied for its potential benefits in adults suffering from short bowel syndrome with intestinal failure (SBS-IF), a rare and chronic condition that requires patients to rely on parenteral support (PS). This condition impacts around 18,000 adults across the U.S., Europe, and Japan.

The highlight of Ironwood’s presentation will be data from the Phase III STARS trial, which investigates the efficacy and safety of once-weekly apraglutide in reducing the need for PS in SBS-IF patients. The company released top-line results from this trial in February 2024, and these findings will be discussed in detail during a late-breaker oral presentation on May 21. The results are also expected to support the submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) and similar regulatory filings globally.

Michael Shetzline, M.D., Ph.D., who serves as Ironwood’s Chief Medical Officer, expressed enthusiasm about sharing further insights from the STARS study. He emphasized the potential of apraglutide as a once-weekly GLP-2 analog for SBS-IF patients dependent on PS. Additionally, Shetzline noted that the company looks forward to presenting real-world data related to their linaclotide portfolio, which targets irritable bowel syndrome with constipation (IBS-C) and functional constipation (FC).

Apart from the oral presentation, Ironwood will present four posters highlighting various aspects of the apraglutide development program. Topics include changes in bowel morphology and motility, parenteral support weaning, clinical benefits, improvements in patient-reported outcomes, and increased oral intake and energy absorption. Another poster will explore apraglutide’s effect on gastric emptying in healthy individuals.

The company will also feature three posters focused on linaclotide, a treatment for IBS-C and FC. These presentations will cover real-world prescribing patterns for pediatric patients, healthcare disparities in IBS diagnosis, and the efficacy, safety, and time to response of linaclotide in patients aged 65 and older.

Apraglutide is an investigational, synthetic GLP-2 analog designed to treat rare GI diseases. Another significant product in Ironwood’s portfolio is LINZESS® (linaclotide), the leading prescription brand in the U.S. for treating adults with IBS-C or chronic idiopathic constipation (CIC). Linaclotide works by increasing intestinal fluid secretion, accelerating transit, and potentially reducing pain-sensing nerve activity in the intestines.

LINZESS is co-developed and co-commercialized in the U.S. by Ironwood and AbbVie. It is marketed under different brand names in various regions; for example, AbbVie sells it as CONSTELLA® in Europe, and Astellas markets it in Japan. Ironwood also collaborates with AstraZeneca for commercialization in China and with AbbVie for other global territories.

Founded in 1998, Ironwood Pharmaceuticals is headquartered in Boston, Massachusetts, with an additional site in Basel, Switzerland. The company focuses on advancing GI disease treatments and aims to set new standards of care for GI patients. Through continued innovation, Ironwood strives to address significant unmet needs in the GI healthcare landscape.