CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Ironwood
Pharmaceuticals, Inc. (NASDAQ: IRWD) announced today that dosing has
begun in a Phase IIa clinical study evaluating whether its
investigational guanylate cyclase-C (GC-C) agonist, IW-9179, can provide
symptomatic relief to patients with diabetic gastroparesis. Data are
expected in the first half of 2016.
"Gastroparesis symptoms, such as nausea and vomiting, are reported by
approximately five to 12 percent of diabetic patients. With few
treatment options available, diabetic gastroparesis represents a
significant unmet need," said Dr. Michael Hall, senior vice president,
clinical development of Ironwood. "The Ironwood team has pioneered
research in GC-C agonist pharmacology, and we utilized this experience
as well as our expertise in gastrointestinal disorders to create
IW-9179. We look forward to evaluating its potential to help diabetic
gastroparesis sufferers."
The randomized, double-blind, placebo-controlled, multi-site Phase IIa
clinical study is expected to enroll approximately 80 adult patients
with diabetic gastroparesis. Patients will be randomized to receive
IW-9179 or placebo orally once or twice daily for four weeks. The study
design includes multiple exploratory endpoints, including
patient-reported daily severity assessments of diabetic gastroparesis
symptoms.
About IW-9179
IW-9179 is an investigational guanylate cyclase-C (GC-C) agonist. GC-C
is a receptor found mainly on the surface of the intestine and is
recognized to be a potential therapeutic target in certain
gastrointestinal diseases. Although GC-C is found throughout the
gastrointestinal tract, IW-9179 is designed to act primarily in the
upper gastrointestinal tract. Ironwood is investigating IW-9179 for the
treatment of gastroparesis, with an initial focus on diabetic
gastroparesis, and for functional dyspepsia, both of which are upper
gastrointestinal disorders characterized by upper abdominal pain,
bloating, fullness and nausea, among other symptoms. Data from a Phase I
study indicate IW-9179 is minimally absorbed and generally
well-tolerated, and initial data from a 10-patient Phase IIa study in
which enrollment was limited by stringent inclusion criteria
suggest IW-9179 may have applicability in patients with functional
dyspepsia. Ironwood is working with gastrointestinal experts and
regulatory authorities to define a path forward for IW-9179 in
functional dyspepsia. The most common adverse event in both studies was
diarrhea. Ironwood has an issued composition of matter patent in the
U.S. covering IW-9179, which expires in 2031, and additional patents are
allowed and pending in the U.S. and throughout the world.
About Gastroparesis
Gastroparesis is an upper gastrointestinal disorder in which the muscles
and/or nerves of the stomach do not function properly, which disrupts
the functional activities of the stomach. Common symptoms of
gastroparesis include nausea, vomiting, bloating, upper abdominal pain
and feelings of fullness after eating just a few bites of food.
Gastroparesis can also result in weight loss and malnutrition. Diabetic
gastroparesis, which is the focus of the current Phase IIa study, is a
condition in which symptoms of gastroparesis occur in patients with type
1 or type 2 diabetes, and has additional harmful effects on glycemic
control, as well as secondary effects on organs, which may lead to
increased mortality. Gastroparesis symptoms are reported by
approximately five to 12 percent of diabetic patients. There are limited
treatment options for gastroparesis available.
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.
Any trademarks referred to in this press release are the property of
their respective owners. All rights reserved.
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-9179; the design of the Phase IIa
study in diabetic gastroparesis, the number of patients expected to be
enrolled, endpoints and the data to be generated, including the impact
on symptoms of diabetic gastroparesis; the completion of the Phase IIa
clinical study and the date on which the data from the study is expected
to be available; the study's impact on future development plans; the
design and potential impact of IW-9179; symptoms, outcomes, available
treatments, unmet need, and IW-9179 as a potential treatment for
gastroparesis and functional dyspepsia; the applicability of IW-9179 in
patients with, and Ironwood's efforts to define a path forward for
IW-9179 in, functional dyspepsia; the strength of the intellectual
property for IW-9179; and the percent of diabetic patients reporting
symptoms of gastroparesis. 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 enroll as many patients in the clinical study or on the
same timeline as we currently anticipate or are otherwise unable to
effectively execute on our clinical program for IW-9179; the risk that
the 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; the
risk that the data from such clinical study are not available when we
currently anticipate them or do not demonstrate efficacy; the risk that
the patient population and the percent of diabetic patients reporting
symptoms of gastroparesis are not as we presently estimate; the risk
that the data from non-clinical studies do not support the data from our
clinical study; those related to decisions made by the U.S. Patent and
Trademark Office and its foreign counterparts, intellectual property
rights of competitors or potential competitors, and the risk that we may
never get sufficient patent protection for IW-9179; 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 September 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.
Ironwood Pharmaceuticals, Inc.
Media Relations
Trista
Morrison, 617-374-5095
Director, Corporate Communications
[email protected]
or
Investor
Relations
Meredith Kaya, 617-374-5082
Director, Investor
Relations
[email protected]
Source: Ironwood Pharmaceuticals, Inc.
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