– IW-3718 Phase II data in patients with
persistent GERD to be featured in oral presentation –
– Data from new patient-reported outcome diary
in IBS-C selected as poster of distinction –
Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused
healthcare company, today announced that the company and its
collaborators will present clinical data for IW-3718, and both
clinical and non-clinical data for linaclotide during Digestive
Disease Week (DDW) being held in San Diego, CA, May 18 through May
21, 2019.
During an oral presentation, Michael Vaezi, M.D., Ph.D., of
Vanderbilt University will share Phase IIb data on the effect of
IW-3718 on a spectrum of symptoms associated with persistent
gastroesophageal reflux disease (GERD) despite treatment with
proton pump inhibitors (PPIs). Additional data will be presented in
poster sessions highlighting the prevalence and significant burden
of illness for patients living with persistent GERD, as well as the
development and validation of a patient-reported outcome instrument
to measure treatment benefit in clinical trials of persistent
GERD.
IW-3718 is being evaluated in Phase III clinical trials for the
treatment of persistent GERD, a condition affecting an estimated 10
million Americans who continue to suffer from heartburn and
regurgitation despite receiving treatment with PPIs, the current
standard of care. Bile acids, which are produced in the intestine
and play an important role in the digestive process, have been
implicated as contributors to GERD symptoms.1,2
With regard to linaclotide, data will be featured in a poster of
distinction which introduces a new patient-reported outcome (PRO)
measure developed for the abdominal symptoms of IBS-C, called the
Diary for Irritable Bowel Syndrome Symptoms—Constipation (DIBSS-C).
The DIBSS-C is being used in an ongoing Phase IIIb study that is
evaluating the efficacy and safety of linaclotide 290 mcg on
multiple abdominal symptoms including pain, bloating and discomfort
in adult patients with IBS-C.
In other poster sessions, researchers will present data on the
expression of the GC-C receptor —the pharmacological target of
linaclotide in IBS-C and CIC—in pediatric patients; real-world
evidence on the use of opioids for pain management among patients
with chronic gastrointestinal disorders including IBS; and
preclinical data on the mechanisms of action of the effect of
linaclotide on visceral pain in the GI tract and in related
visceral organs.
The data will be presented as follows:
Phase II Data on Effect of IW-3718 on a Spectrum of GERD
Symptoms in Patients with Persistent GERD (Oral
Presentation)
- Impact of IW-3718, a Novel
Gastric-Retentive Bile-Acid Sequestrant, on a Spectrum of GERD
Symptoms in Patients with Persistent GERD Receiving PPIs – Results
from a Double-Blind, Placebo-Controlled Study (oral presentation
#12), by Michael Vaezi, M.D., Ph.D., Vanderbilt University Medical
Center, Nashville, TN, et al. will be presented at the Advances in
the Management of Gastroesophageal Reflux Disease session on
Saturday, May 18, 8:45 a.m. to 9:00 a.m., in Room 7 of the San
Diego Convention Center.
Patient Experience in GERD
- Prevalence and Profile of Patients with
Persistent GERD Symptoms despite PPI Treatment: Interim Results
from a Cross-Sectional Patient Survey (poster session Sa1199), by
Douglas Taylor, Ironwood Pharmaceuticals, Inc., Cambridge, MA, et
al. will be presented at the GERD: Medical, Surgical and Endoscopic
Therapies session on Saturday, May 18, Noon to 2:00 p.m., in Halls
C-E of the San Diego Convention Center.
Patient-Reported Outcome Measures (i) in Persistent GERD, and
(ii) in IBS-C
- Measuring Heartburn Severity and
Regurgitation Frequency Using the MRESQ-eD in a Persistent GERD
Population: Phase 2b Clinical Trial Data (poster session Sa1191),
by David Andrae, Ph.D., Endpoint Outcomes, Boston, MA, et al. will
be presented at the GERD: Complications and Extraesophageal
Presentations session on Saturday, May 18, Noon to 2:00 p.m., in
Halls C-E of the San Diego Convention Center.
- New Patient- Reported Outcome Measure:
Diary for Irritable Bowel Syndrome Symptoms—Constipation,
Guidelines for Interpretation of Change in Abdominal Symptoms Using
Phase 2b Clinical Trial Data (poster of distinction session
Su1587), by Cheryl Coon, Ph.D., Outcometrix, Essex, MA, et al. will
be presented at the Functional GI Disorders I session on Sunday,
May 19, Noon to 2:00 p.m., in Halls C-E of the San Diego Convention
Center.
Opioid Use in Pain Management in GI Disorders
- Estimation of Opioid Use for the
Management of Pain Among Patients with Chronic Gastrointestinal
Disorders (poster session Su1598), by Jean Lim, Ironwood
Pharmaceuticals, Inc., Cambridge, MA, et al. will be presented at
the Functional GI Disorders I session on Sunday, May 19, Noon to
2:00 p.m., in Halls C-E of the San Diego Convention Center.
GC-C Receptor Levels in the GI Tract of a Pediatric
Population
- Intestinal Guanylate Cyclase C mRNA
Expression is Similar Across Children Aged 6 months to <18 Years
and is Greater in the Duodenum as Compared to the Colon (poster
session Sa1127), by Mitchell Cohen, MD, University of Alabama at
Birmingham, Birmingham, AL, et al. will be presented at the Growth
and Developmental Biology session on Saturday, May 18, Noon to 2:00
p.m., in Halls C-E of the San Diego Convention Center.
Effect of Linaclotide on Colonic Hypersensitivity
- GC-C Agonism with Linaclotide
Attenuates Chronic Stress-Induced Colonic Hypersensitivity
Independently of Elevated CRF Expression in the Central Nucleus of
the Amygdala (poster session Sa1681), by Casey Ligon, Oklahoma
Center for Neuroscience, Oklahoma City, OK, et al. will be
presented at the IBS: Pathophysiology session on Saturday, May 18,
Noon to 2:00 p.m., in Halls C-E of the San Diego Convention
Center.
- Chronic Intracolonic Administration of
Linaclotide Inhibits Nociceptive Signaling in a Mouse Model of
Chronic Visceral Hypersensitivity (poster session Su1578), by
Stuart Brierley, Ph.D., Flinders University and University of
Adelaide, Adelaide, AUS, et al. will be presented at the IBS:
Pathophysiology session on Sunday, May 19, Noon to 2:00 p.m., in
Halls C-E of the San Diego Convention Center.
- Chronic Colonic Administration of the
Guanylate Cyclase-C Agonist Linaclotide Attenuates Colitis Induced
Bladder Afferent Hyperactivity (poster session Sa1677), by Luke
Grundy, Ph.D., Flinders University and University of Adelaide,
Adelaide, AUS, et al. will be presented at the IBS: Pathophysiology
session on Saturday, May 18, Noon to 2:00 p.m., in Halls C-E of the
San Diego Convention Center.
About IW-3718
IW-3718 is a novel, gastric-retentive investigational
formulation of colesevelam, a bile-acid sequestrant, developed by
Ironwood using the proprietary Acuform® drug delivery formulation
technology licensed from Assertio Therapeutics, 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 issued 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). Linaclotide is marketed by Allergan
for the treatment of adults with moderate to severe IBS-C in Europe
under the brand name CONSTELLA®. Ironwood is partnered with
AstraZeneca for development and commercialization of linaclotide in
China, Hong Kong and Macau. Astellas has the exclusive rights to
develop and commercialize linaclotide in Japan. Allergan has rights
to develop and market in the remaining rest of world countries.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (Nasdaq: IRWD) is a GI-focused
healthcare company dedicated to creating medicines that make a
difference for patients living with GI diseases. 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).
We are currently advancing a Phase IIIb trial evaluating the
efficacy and safety of linaclotide on multiple abdominal symptoms,
including bloating, pain, and discomfort, in adult patients with
IBS-C.
We are also advancing two late-stage, first-in-category GI
product candidates: IW-3718 is a gastric-retentive formulation of a
bile-acid sequestrant being developed for the potential treatment
of persistent gastroesophageal reflux disease. MD-7246 is a
delayed-release formulation of linaclotide that is being evaluated
as an oral, intestinal, non-opioid, pain-relieving agent for
patients suffering from abdominal pain associated with IBS with
diarrhea.
Ironwood was founded in 1998 and is headquartered in Cambridge,
Mass. For more information, please visit our website at
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 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.
Forward-Looking Statements
This press release contains forward-looking statements.
Investors are cautioned not to place undue reliance on these
forward-looking statements, including statements about the
prevalence of persistent GERD; the development, validation and use
of patient-reported outcome instruments to measure treatment
benefit in clinical trials; the mechanism of action of IW-3718; the
mechanism of action of the effect of linaclotide on visceral pain
in the GI tract and in related visceral organs; and the expected
period of patent coverage for IW-3718.
Each forward‐looking statement is subject to risks and
uncertainties that could cause actual results to differ materially
from those expressed or implied in such statement. Applicable risks
and uncertainties include those related to preclinical and clinical
development, manufacturing and formulation development; the risk
that findings from our completed non-clinical and clinical studies
may not be replicated in later studies; efficacy, safety and
tolerability of our products and product candidates; decisions by
regulatory and judicial authorities; the risk that we are unable to
successfully commercialize our products and product candidates, if
approved; the risk that we may never get sufficient patent
protection for our products and product candidates or that we are
not able to successfully protect such patents; the outcomes in
legal proceedings to protect or enforce the patents relating to our
products and product candidates; developments in the intellectual
property landscape; challenges from and rights of competitors or
potential competitors; the risk that our planned investments do not
have the anticipated effect on our company revenues, products or
product candidates; the risk that we are unable to manage our
operating expenses or cash use for operations, or are unable to
commercialize our products, within the guided ranges or otherwise
as expected; and the risks listed under the heading "Risk Factors"
and elsewhere in Ironwood's Quarterly Report on Form 10-Q for the
quarter ended March 31, 2019, and in our
subsequent SEC filings. These forward-looking statements
(except as otherwise noted) speak only as of the date of this press
release, and Ironwood undertakes no obligation to update these
forward-looking statements.
1 Bachir G. S., Leigh-Collis J., Wilson P., & Pollak E. W.
(1981). Diagnosis of incipient reflux esophagitis: a new test.
Southern Medical Journal, 74(9), 1072-4.2 Vaezi M. F., &
Richter J. E. (1998). Contribution of acid and
duodenogastro-oesophageal reflux to oesophageal mucosal injury and
symptoms in partial gastrectomy patients. Gut, 41, 297-302.
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version on businesswire.com: https://www.businesswire.com/news/home/20190509005106/en/
Meredith Kaya, 617-374-5082Vice President, Investor Relations
and Corporate Communicationsmkaya@ironwoodpharma.com
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