– Data to be featured in two oral presentations and six posters – – CEO Tom McCourt to receive American Society for Gastrointestinal Endoscopy (ASGE) President’s Award at meeting –
BOSTON--(BUSINESS WIRE)-- Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today announced that the company and its collaborators will present eight studies, including two oral presentations, during the Digestive Disease Week® (DDW) 2022 meeting being held from May 21 through May 24, 2022 in San Diego, CA.
One oral presentation will discuss the impact of novel guanylate cyclase-C agonist IW-3300 on comorbid chronic pelvic and somatic pain in a preclinical model of stress-induced visceral hypersensitivity. Ironwood is focused on advancing the science and understanding of visceral pain and is currently developing IW-3300 for the potential treatment of chronic visceral pain conditions, such as interstitial cystitis/bladder pain syndrome (IC/BPS) and endometriosis. The second oral presentation will summarize results of a post-hoc analysis of linaclotide studies focused on further understanding its treatment effect on abdominal symptoms in patients with Irritable Bowel Syndrome with Constipation (IBS-C). Other studies include preclinical data on the impact of linaclotide on visceral hypersensitivity, data on the impact of linaclotide on pediatric functional constipation (FC) and studies on disease burden of IBS-C and chronic idiopathic constipation (CIC).
At the meeting, Ironwood’s Chief Executive Officer, Tom McCourt will be honored with the American Society for Gastrointestinal Endoscopy (ASGE) President’s Award, which recognizes individuals who have made exceptional contributions to ASGE and its mission over the course of their careers.
“DDW is always an invigorating meeting for scientific minds in the GI community, and we’re thrilled to share findings from eight insightful studies in person this year,” said Mr. McCourt. “We’re particularly excited to showcase new research emphasizing our leadership in the visceral hypersensitivity space, specifically exploring IW-3300’s potential as a treatment option for visceral pain conditions. We are also delighted to share new data that informs our understanding of linaclotide’s treatment effect in patients with IBS-C and from its development program in pediatric patients with functional constipation. In addition, I am honored and humbled to be receiving the ASGE President's Award. I truly believe that when industry and professional organizations work collaboratively, we best position ourselves to advance science and public health.”
In addition to two oral presentations, four additional topics will be presented and two ePosters will be available by Ironwood as well. An overview of all eight presentations is provided below.
IW-3300
- Colon-Targeted Delivery Of Guanylate Cyclase-C Agonist IW-3300 Relieves Comorbid Chronic Pelvic And Somatic Pain In A Rat Model Of Early Life Stress-Induced Colonic Hypersensitivity (oral presentation; presentation number 240), by Casey Ligon, Ph.D., The University of Oklahoma Health Sciences Center, Oklahoma City, OK, will be presented on Saturday, May 21, 4:45 p.m. to 5:00 p.m. PT in room 24
Linaclotide
- Patient-Derived Meaningful Change Thresholds In The Novel Abdominal Score Outcome Measure In Irritable Bowel Syndrome With Constipation (oral presentation; presentation number 179), by Jan Tack, M.D., Ph.D., University of Leuven, Leuven, Belgium, will be presented on Saturday, May 21, 3:00 p.m. to 3:15 p.m. PT in Room 28ABC
- Undiagnosed Irritable Bowel Syndrome with Constipation (IBS-C) and Chronic Idiopathic Constipation (CIC): More Common than we Thought? (presentation number Mo1084), by Brian E. Lacy, M.D., Ph.D., The Mayo Clinic, Jacksonville, FL, will be presented on Monday, May 23, 12:30 p.m. to 1:30 p.m. PT
- Chronic Idiopathic Constipation Sufferers And Treatment Satisfaction: Prescription Vs. Over-The-Counter Medication (presentation number Tu1339), by Brian E. Lacy, M.D., Ph.D., The Mayo Clinic, Jacksonville, FL, on Tuesday, May 24, 12:30 p.m. to 1:30 p.m. PT
- Race-Related Comparisons Of Irritable Bowel Syndrome With Constipation Symptoms, Treatment Response, And Quality Of Life: Results Of A Pooled Analysis Of Linaclotide Clinical Trials (presentation number Tu1364), by Linda Nguyen, M.D., Stanford Health Care, Redwood City, CA, on Tuesday, May 24, 12:30 p.m. to 1:30 p.m. PT
- Safety and Efficacy of Linaclotide in Children Aged 2-5 years With Functional Constipation; Results From a Randomized, Double-blind, Placebo-controlled, Multidose Study (presentation number Tu1390), by Carlo Di Lorenzo, M.D., Nationwide Children’s Hospital, Columbus, OH, on Tuesday, May 24, 12:30 p.m. to 1:30 p.m. PDT
- Colorectal Nociceptive Processing In Ascending Pain Relaying Caudal Ventrolateral Medulla And The Lateral Parabrachial Nuclei Is Increased In A Mouse Model Of Chronic Visceral Hypersensitivity And Is Reversed By Chronic Linaclotide Treatment (ePoster presentation number EP1238), by Andrea Harrington, Ph.D., Flinders University, Adelaide, South Australia
- Descending Pain Modulation Of Colorectal Nociceptive Processing In The Spinal Cord Is Imbalanced In A Mouse Model Of Post-Colitis Chronic Visceral Hypersensitivity And Is Reduced By Chronic Oral Linaclotide Treatment (ePoster presentation number EP1239), by Andrea Harrington, Ph.D., Flinders University, Adelaide, South Australia
About Linaclotide Linaclotide is a guanylate cyclase-C (GC-C) agonist that is thought to work in two ways based on nonclinical studies. Linaclotide binds to the GC-C receptor locally, within the intestinal epithelium. Activation of GC-C results 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 chronic constipation. In China, (including Hong Kong and Macau) Ironwood’s partner Astra Zeneca markets linaclotide under the brand name LINZESS for the treatment of adults with IBS-C. Ironwood is also partnered with AbbVie for development and commercialization of linaclotide in all other territories worldwide. LINZESS® and CONSTELLA® are registered trademarks of Ironwood Pharmaceuticals, Inc. Any other trademarks referred to in this press release are the property of their respective owners. All rights reserved.
LINZESS Important Safety Information INDICATIONS AND USAGE LINZESS (linaclotide) is indicated in adults for the treatment of both irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC). 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
- LINZESS is contraindicated in patients less than 2 years of age due to the risk of serious dehydration.
- LINZESS is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.
Warnings and Precautions Pediatric Risk
- LINZESS is contraindicated in patients less than 2 years of age. In neonatal mice, linaclotide increased fluid secretion as a consequence of age-dependent elevated GC-C agonism resulting in mortality within the first 24 hours due to dehydration. There was no age-dependent trend in GC-C intestinal expression in a clinical study of children 2 to less than 18 years of age; however, there are insufficient data available on GC-C intestinal expression in children less than 2 years of age to assess the risk of developing diarrhea and its potentially serious consequences in these patients. The safety and effectiveness of LINZESS in patients less than 18 years of age have not been established.
Diarrhea
- Diarrhea was the most common adverse reaction in LINZESS-treated patients in the pooled IBS-C and CIC double-blind placebo-controlled trials. The incidence of diarrhea was similar in the IBS-C and CIC populations. Severe diarrhea was reported in 2% of 145 mcg and 290 mcg LINZESS-treated patients, and in