Ironwood Pharmaceuticals Presenting IW-3718 and Linaclotide Data at the American College of Gastroenterology
2018 Annual Scientific Meeting
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a commercial biotechnology company, today announced the presentation of clinical
data for IW-3718 and linaclotide from the company and its collaborators during the American College of Gastroenterology 2018 Annual
Scientific Meeting in Philadelphia, PA, October 5 through October 10, 2018.
IW-3718 is being evaluated in Phase III clinical trials for the treatment of persistent gastroesophageal reflux disease (GERD).
Persistent GERD is a condition affecting an estimated 10 million Americans who continue to suffer from heartburn and regurgitation
despite receiving treatment with proton pump inhibitors, the current standard of care. Researchers will present analyses of
Ironwood’s Phase IIb data on the effect of IW-3718 on health-related quality of life in patients with persistent GERD, as well as
data on the effect of IW-3718 on esophageal erosions in this patient population.
Linaclotide is a guanylate cyclase?C (GC?C) agonist that acts by a mechanism pioneered by Ironwood scientists. Linaclotide is
marketed in the United States as LINZESS® and is the U.S. branded prescription market leader for adults with Chronic
Idiopathic Constipation (CIC) or Irritable Bowel Syndrome with Constipation (IBS-C). It is also marketed in Japan as LINZESS for
the treatment of adults with IBS-C and adults with chronic constipation, and in Europe as CONSTELLA® for the treatment
of adults with moderate to severe IBS-C. Researchers will present an analysis of clinical data focusing on the impact of
linaclotide on constipation symptoms and quality of life in patients with IBS-C or CIC. An additional presentation will focus on
treatment patterns in patients with IBS-C or CIC.
The data via poster presentations is as follows:
Treatment Impact on Patients with IBS-C or CIC
- Treatment Patterns, Over-the-Counter (OTC) Use, and Outcomes among Patients with Irritable Bowel
Syndrome with Constipation or Chronic Idiopathic Constipation: Results from the CONTOR Study (poster session #P0331), by
Douglas C.A. Taylor, MBA, Ironwood Pharmaceuticals, Inc., Cambridge, MA, was presented on Sunday, October 7, 5:15 p.m. to 6:30
p.m., in Exhibit Halls DE of the Pennsylvania Convention Center.
- Impact of Linaclotide on Patient-Reported Constipation Symptoms and Quality of Life: Results from
the CONTOR Study (poster session #P0332), by Douglas C.A. Taylor, MBA, Ironwood Pharmaceuticals, Inc., Cambridge, MA, was
presented on Sunday, October 7, 5:15 p.m. to 6:30 p.m., in Exhibit Halls DE of the Pennsylvania Convention Center.
Effect of IW-3718 on Patients with Persistent GERD
- Clinical Response is Associated with Improvement in Health-Related Quality of Life in Patients
with Persistent GERD Symptoms (poster session #P2019), by Hancheng Jiang, M.S., Ironwood Pharmaceuticals, Inc., Cambridge,
MA, will be presented on Tuesday, October 9, 1:00 p.m. to 2:15 p.m., in Exhibit Halls DE of the Pennsylvania Convention
Center.
- Effects of a Gastric-Retentive Extended-Release Bile Acid Sequestrant on Esophageal Erosions in
Patients with Persistent GERD; Exploratory Analysis from a Phase IIb Study of IW-3718 (poster session #P2026), by Peter
Kahrilas, M.D., Northwestern University Feinberg School of Medicine, Chicago, IL, will be presented on Tuesday, October 9, 1:00
p.m. to 2:15 p.m., in Exhibit Halls DE of the Pennsylvania Convention Center.
About IW-3718
IW-3718 is a novel, gastric retentive formulation of colesevelam, a bile acid sequestrant, developed by Ironwood using the
proprietary Acuform® drug delivery formulation technology licensed from Depomed, Inc. IW-3718 is designed to deliver the
bile acid sequestrant to the stomach over an extended period of time where it is positioned to intercept bile before it reaches the
esophagus. Data from non-clinical and clinical studies collectively support the extended release and gastric-retentive profile of
IW-3718. Ironwood has existing patents and pending patent applications for IW-3718 that are expected to provide patent coverage
into the mid-2030s.
About Persistent Gastroesophageal Reflux Disease (GERD)
An estimated 10 million adult Americans and more than 60 million adult patients globally suffer from persistent gastroesophageal
reflux disease (GERD), meaning they continue to experience symptoms such as heartburn and regurgitation despite receiving treatment
with a proton pump inhibitor (PPI). While PPIs suppress production of stomach acid, Ironwood’s clinical research demonstrates that
reflux of bile from the intestine into the stomach and esophagus may play a key role in the ongoing symptoms of persistent GERD.
FDA-approved treatment options for these patients are limited.
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. Linaclotide is
marketed by Ironwood and Allergan plc in the United States as LINZESS and is indicated for the treatment
of adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC), with nearly 2 million
unique patients in the United States having filled nearly 11 million linaclotide prescriptions since launch, according
to IQVIA. Linaclotide is marketed by Allergan for the treatment of adults with moderate to severe IBS-C
in Europe under the brand name CONSTELLA. Astellas has the exclusive rights to develop and commercialize linaclotide
in Japan. Ironwood also has partnered with AstraZeneca for development and commercialization of linaclotide
in China, Hong Kong and Macau.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (Nasdaq: IRWD) is a commercial biotechnology company focused on creating medicines that make a
difference for patients, building value for our fellow shareholders, and empowering our passionate team. We discovered, developed
and are commercializing linaclotide, the U.S. branded prescription market leader for adults with irritable bowel syndrome with
constipation (IBS-C) or chronic idiopathic constipation (CIC). Our pipeline priorities for linaclotide include a Phase IIIb trial
evaluating its efficacy and safety on multiple abdominal symptoms, including abdominal bloating, pain, and discomfort in adult
patients with IBS-C, as well as research into a formulation of linaclotide designed to relieve pain across all IBS subtypes.
We are also advancing a pipeline of innovative product candidates in areas of significant unmet need, including persistent
gastroesophageal reflux disease, diabetic nephropathy, heart failure with preserved ejection fraction and sickle cell disease.
Ironwood was founded in 1998 and is headquartered in Cambridge, Mass. For more information, please visit
www.ironwoodpharma.com or
www.twitter.com/ironwoodpharma; information that may be important to investors will be routinely posted in both these
locations.
LINZESS and CONSTELLA are trademarks of Ironwood Pharmaceuticals, Inc. Any other trademarks referred to in this press
release are the property of their respective owners. All rights reserved.
Ironwood Pharmaceuticals, Inc.
Investor Relations:
Meredith Kaya, 617-374-5082
Vice President, Investor Relations and Corporate Communications
mkaya@ironwoodpharma.com
or
Media Relations:
Maryann Quinn, 617-374-3952
Director, Corporate Communications
mquinn@ironwoodpharma.com
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