CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct. 8, 2018--
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20181008005125/en/
Source: Ironwood Pharmaceuticals, Inc.
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