Ironwood
Pharmaceuticals, Inc. (NASDAQ:IRWD) announced today the presentation
of initial data from a Phase IIa clinical study in functional dyspepsia
with IW-9179, an investigational guanylate cyclase-C (GC-C) agonist
designed to target the upper gastrointestinal (GI) tract. These data
will be presented during the American College of Gastroenterology 2014
Annual Scientific Meeting in Philadelphia, October 17 through October
22, 2014. Ironwood expects to initiate a Phase IIa clinical study
evaluating IW-9179 in a second therapeutic area, gastroparesis, before
the end of the year. Gastroparesis is an upper GI disorder that impacts
an estimated 9 million Americans and is characterized by nausea,
vomiting, bloating, early satiety and pain.
“As innovators in the science of guanylate cyclase-C, Ironwood created
the first and only FDA-approved GC-C agonist, which is indicated for two
lower gastrointestinal disorders. We are encouraged by the initial
IW-9179 data and our other recent data indicating GC-C agonists may also
have utility in treating upper gastrointestinal disorders,” said Dr.
Michael Hall, MB. BCh., senior vice president, clinical development of
Ironwood. “Common upper GI disorders such as gastroparesis and
functional dyspepsia remain areas where millions of suffering patients
are in need of effective therapies.”
The Phase IIa clinical study of IW-9179 was a randomized, double-blind
study in 10 patients (six on IW-9179, four on placebo) with functional
dyspepsia (FD). Patients treated with IW-9179 reported a numerically
greater improvement from baseline, compared with placebo-treated
patients, on six out of seven FD symptoms evaluated, including
epigastric pain, epigastric bloating, postprandial fullness, early
satiation, nausea and belching. The most common adverse event in
IW-9179-treated patients was diarrhea. Enrollment in this study was
limited by stringent enrollment criteria that sought to identify
patients suffering only from GI symptoms of FD - a difficult task given
that FD sufferers frequently also have symptoms of other GI disorders
such as gastroesophageal reflux disease (GERD) or irritable bowel
syndrome (IBS). In fact, of the 58 patients who initially met the
stringent enrollment criteria and completed the 14-day pretreatment
period, 78% were not qualified to enter the study treatment period owing
to overlapping GI symptoms. These data inform Ironwood’s continued work
with gastrointestinal experts and regulatory authorities to define the
path to bring forward new therapies in FD.
These data will be presented in the poster, Evaluation of Daily GI
Symptoms in a Phase 2a Study of IW-9179 in Functional Dyspepsia
(abstract #P1637) on Tuesday, October 21, 2014, 10:30 a.m. to 4:00 p.m.,
Eastern Time. Jan Tack, MD, Ph.D., Head of Clinic in the Department of
Gastroenterology, and Professor of Internal Medicine at the University
of Leuven, Belgium, is the lead investigator and first author.
About Functional Dyspepsia
Functional dyspepsia is an upper gastrointestinal disorder characterized
by key symptoms of epigastric pain, epigastric bloating, postprandial
fullness, epigastric burning, nausea, belching, and early satiety. It is
estimated to impact 35 million Americans, and there are currently no
treatment options approved by the Food and Drug Administration.
About Gastroparesis
Gastroparesis is an upper gastrointestinal disorder in which the muscles
and/or nerves of the stomach do not function properly, which prevents
the stomach from emptying. Common symptoms include nausea, vomiting,
bloating, early satiety and pain. Gastroparesis is estimated to impact 9
million Americans, and there are limited treatment options available.
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About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (NASDAQ: IRWD) is focused on creating medicines
that make a difference for patients, building value to earn the
continued support of our fellow shareholders, and empowering our team to
passionately pursue excellence. We discovered, developed and are
commercializing linaclotide, which is approved in the United States and
a number of other countries. Our pipeline priorities include exploring
further opportunities for linaclotide, as well as leveraging our
therapeutic expertise in gastrointestinal disorders and our
pharmacologic expertise in guanylate cyclases to address patient needs
across the upper and lower gastrointestinal tract. Ironwood was founded
in 1998 and is headquartered in Cambridge, Mass. Connect with us at www.ironwoodpharma.com
or on Twitter at www.twitter.com/ironwoodpharma;
information that may be important to investors will be routinely posted
in both these locations.
This press release contains forward-looking statements. Investors are
cautioned not to place undue reliance on these forward-looking
statements, including, but not limited to, statements about the size,
scope and design of the IW-9179 development program and the associated
clinical studies and development plans; the initiation of clinical
studies and the timing thereof; the completion of clinical studies, the
data generated and the impact of such data on future development plans;
functional dyspepsia and gastroparesis symptoms, available treatments
and the effectiveness of GC-C agonists to treat these disorders as well
as other upper gastrointestinal disorders; the overlap of symptoms
across GI disorders; Ironwood’s efforts to bring new therapies in
functional dyspepsia; the size of potential patient populations; and the
timing, location and content of presentations. 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, but are not
limited to, the risk that we are unable to initiate, enroll, and
complete clinical studies on the same timeline as we currently
anticipate or otherwise are unable to effectively execute on our IW-9179
development program; the risk that a clinical study needs to be
discontinued for any reason, including safety, efficacy, tolerability,
enrollment, manufacturing or economic reasons; those related to
decisions made by regulatory authorities; those related to our ability
to bring new therapies in functional dyspepsia, gastroparesis and other
upper gastrointestinal disorders; the risk that the data from clinical
studies is not available when we currently anticipate it or does not
demonstrate efficacy; the risk that the data from non-clinical studies
does not support the data from our clinical studies; the risk that the
patient population is not as large as we presently estimate; and those
risks related to competition and future business decisions made by
Ironwood and its competitors or potential competitors. Applicable risks
also include those that are listed under the heading "Risk Factors" and
elsewhere in Ironwood's Quarterly Report on Form 10-Q for the quarter
ended June 30, 2014, in addition to the risk factors that are listed
from time to time in Ironwood's Annual Reports on Form 10‐K, Quarterly
Reports on Form 10‐Q and any other subsequent SEC filings. Ironwood
undertakes no obligation to update these forward-looking statements to
reflect events or circumstances occurring after this press release.
Except as otherwise noted, these forward-looking statements speak only
as of the date of this press release. All forward‐looking statements are
qualified in their entirety by this cautionary statement.
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