– Data from pivotal Phase III STARS study in short bowel syndrome with intestinal failure (SBS-IF) accepted as late-breaker oral presentation on May 21 at 10:30 am ET –
– Findings from the STARS Nutrition Study in SBS-IF will be highlighted in poster presentations –
– Additional posters will focus on linaclotide, irritable bowel syndrome with constipation and functional constipation –
BOSTON--(BUSINESS WIRE)-- 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 inadults withirritable 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
Irritable Bowel Syndrome with Constipation and Functional Constipation
About Apraglutide
Apraglutide is an investigational, 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 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
Warnings and Precautions
Diarrhea