CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Ironwood
Pharmaceuticals, Inc. (NASDAQ: IRWD) announced today that dosing has
begun in its Phase IIa clinical study of its investigational compound
IW-3718 in patients suffering from gastroesophageal reflux disease
(GERD) who have not responded adequately to treatment with a proton pump
inhibitor (PPI). Data are expected in the first half of 2015.
"There are an estimated 7 million patients in the U.S. who suffer
regularly from symptoms of GERD - such as heartburn and regurgitation -
despite receiving the current standard of care of treatment with a
proton pump inhibitor to suppress stomach acid production. For many of
these refractory GERD patients, research suggests reflux of bile acid
from the intestine into the stomach and esophagus may play an important
role in their ongoing suffering," said Michael Hall, MB. BCh., senior
vice president, clinical development of Ironwood. "Refractory GERD is a
significant unmet need among those suffering with gastrointestinal
disorders, and we are investigating IW-3718 to assess whether it may
help prevent bile acid reflux and provide relief for patients."
Preliminary findings from non-clinical studies conducted by Ironwood and
collaborators have shown that bile acids can cause relaxation (opening)
of the lower esophageal sphincter, which allows reflux of contents from
the stomach into the esophagus. Bile and bile acids were also shown to
cause increased activity of esophageal nerve fibers in related
non-clinical studies. Importantly, these study data suggest that a bile
acid sequestrant may be able to block these actions. Collectively, these
and other data provide additional evidence to suggest that bile acids
could play a role in the pathophysiology of refractory GERD, and that a
targeted bile acid sequestrant could have therapeutic utility in the
treatment of this disorder.
IW-3718 is a novel gastric retention formulation of a bile acid
sequestrant, created by Ironwood, and co-developed with Depomed Inc.
through incorporation of its proprietary Acuform® drug delivery
technology. IW-3718 is designed to deliver the bile acid sequestrant to
the desired sites of action - specifically the stomach and duodenum
(upper small intestine) - over an extended period of time. Data from
non-clinical studies support the extended release profile of IW-3718.
Ironwood is evaluating IW-3718 in a randomized, double-blind,
placebo-controlled, multi-site Phase IIa clinical trial. The trial is
expected to enroll approximately 90 patients with a confirmed diagnosis
of gastroesophageal reflux disease who are taking a PPI and continuing
to experience GERD symptoms. Patients will continue to take their PPI
with the addition of either IW-3718 or placebo. The exploratory Phase
IIa trial will evaluate a number of different GERD symptoms and efficacy
endpoints as well as safety and tolerability of IW-3718. More
information on the trial can be found here.
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, the
European Union, 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 and
scope of the clinical program for IW-3718, the completion of the Phase
II clinical study and the date in which the data from the study will be
available, the size of the potential patient population, and the cause
of the symptoms suffered by the potential patient population. 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,
without limitation, the risk that we are unable to enroll as many
patients in the clinical study or on the same timeline as we currently
anticipate; the clinical study needs to be discontinued for any reason,
including safety, manufacturing or economic reasons; the data from such
clinical study is not available when we currently anticipate it; the
patient population is not as large as we presently estimate; and the
data from non-clinical studies does not support the data from our
clinical study. Applicable risks also include those listed under the
heading "Risk Factors" and elsewhere in Ironwood's Annual Report on Form
10-K for the year ended December 31, 2013, 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 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.
Ironwood Pharmaceuticals, Inc.
Media Relations
Trista
Morrison, 617-374-5095
Associate Director, Corporate Communications
tmorrison@ironwoodpharma.com
or
Investor
Relations
Mary Conway, 617-621-8308
Investor Relations
mconway@ironwoodpharma.com
Source: Ironwood Pharmaceuticals, Inc.
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