Ironwood Pharmaceuticals to Present New Data on Once-Weekly Apraglutide in Short Bowel Syndrome with Intestinal Failure (SBS-IF) at Digestive Disease Week 2024

Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, announced today that the company will present new data from studies evaluating apraglutide in adults with short bowel syndrome with intestinal failure (SBS-IF), a condition in which patients are dependent on parenteral support (PS), during the 2024 Digestive Disease Week (DDW) meeting. DDW is held from May 18-21, 2024, in Washington, D.C.

SBS-IF, a rare chronic debilitating malabsorptive condition in which patients are dependent on PS, affects an estimated 18,000 adult patients in the U.S., Europe, and Japan. Apraglutide data from the STARS Phase III trial, which evaluated the safety and efficacy of once-weekly apraglutide in reducing PS dependency in adult patients with SBS-IF, will be presented at DDW 2024 as a late-breaker oral presentation. Ironwood announced topline data from the STARS Phase III trial in February 2024.

The late-breaker presentation includes new apraglutide data from the STARS Phase III trial. Based on these results, the company is working to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) and other regulatory filings for apraglutide for use in adult patients with SBS who are dependent on PS.

“Coming off our recently announced positive topline results from STARS, we’re excited to share additional study findings that underscore the importance of apraglutide as a potential once-weekly GLP-2 analog for adult patients with SBS who are dependent on parenteral support,” said Michael Shetzline, M.D., Ph.D., chief medical officer, senior vice president and head of research and drug development at Ironwood Pharmaceuticals. “We also look forward to showcasing additional real-world insights related to our IBS-C and FC linaclotide portfolio.”

In addition to the oral presentation, a series of four posters will highlight findings across the apraglutide development program. Also, three posters will spotlight data on linaclotide in adults with irritable bowel syndrome with constipation (IBS-C), disparities in IBS diagnosis, and real-world prescribing patterns for pediatric patients with functional constipation (FC) and IBS-C. A list of the data presentations is below.

Apraglutide in SBS-IF

• Efficacy and Safety of Apraglutide Once-Weekly in Patients with Short Bowel Syndrome and Intestinal Failure (SBS-IF): Results from the STARS Study - A Global Phase 3 Double-Blind, Randomized, Placebo-Controlled Trial
  • Oral presentation: May 21, 10:30 – 10:45 am ET.
• Changes in Bowel Morphology and Motility Assessed by MRI in Patients with Short Bowel Syndrome Intestinal Failure (SBS-IF) and Colon-In-Continuity Treated with Apraglutide
  • Poster presentation number Su1946: May 19, 12:30 – 1:30 pm ET.
• Parenteral Support Weaning, Clinical Benefit and Improved Patient Reported Outcomes in Short Bowel Syndrome Intestinal Failure (SBS-IF) Patients with Colon-In-Continuity Treated with the Long-Acting Glucagon-Like Peptide-2 (GLP-2) Analog Apraglutide
  • Poster presentation number Su1947: May 19, 12:30 – 1:30 pm ET.
• Apraglutide Treatment in Short Bowel Syndrome with Intestinal Failure (SBS-IF) and Colon-In-Continuity is Associated with Increased Oral Intake and Improved Energy and Carbohydrate Absorption at 48 Weeks
  • Poster presentation number Su1948: May 19, 12:30 – 1:30 pm ET.
• The Effect of Apraglutide on Gastric Emptying in Healthy Individuals: A Phase 1 Randomized, Placebo-Controlled, Double-Blind, Single-Center Trial
  • Poster presentation number Su1949: May 19, 12:30 – 1:30 pm ET.

Irritable Bowel Syndrome with Constipation and Functional Constipation