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Ironwood Pharmaceuticals to Highlight IW-3718 and Linaclotide Data at Digestive Disease Week® 2019

BusinessWire

– 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 –

CAMBRIDGE, Mass.–(BUSINESS WIRE)–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)

Patient Experience in GERD

Patient-Reported Outcome Measures (i) in Persistent GERD, and (ii) in
IBS-C

Opioid Use in Pain Management in GI Disorders

GC-C Receptor Levels in the GI Tract of a Pediatric Population

Effect of Linaclotide on Colonic Hypersensitivity

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.

Contacts

Meredith Kaya, 617-374-5082
Vice President, Investor Relations and
Corporate Communications
mkaya@ironwoodpharma.com

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