Ironwood
Pharmaceuticals, Inc. (NASDAQ: IRWD) announced today that top-line
data from an exploratory Phase IIa clinical study indicate IW-9179 did
not meaningfully reduce the severity of symptoms in patients with
diabetic gastroparesis. Based on these data, Ironwood intends to
discontinue development of IW-9179 for gastroparesis.
“Our mission is to bring innovative medicines to patients in need, and
exploratory trials are designed to help us identify the investigational
medicines and appropriate indications with the most potential to help
patients,” said Mark Currie, Ph.D., chief scientific officer and
president of research and development at Ironwood. “While these data
indicate IW-9179 does not warrant advancement for gastroparesis, we
recognize gastroparesis as a severely underserved disorder, and we want
to extend our gratitude to the patients and health care professionals
who participated in this study.”
The Phase IIa study was a randomized, double-blind, placebo-controlled
study of oral IW-9179 administered to 90 patients with diabetic
gastroparesis. Patients were randomized to receive IW-9179 or placebo
once or twice daily for four weeks. Efficacy was evaluated through
multiple patient assessments of cardinal symptoms associated with
gastroparesis. Top-line data indicate IW-9179 did not meaningfully
improve these symptoms relative to placebo. IW-9179 was generally
well-tolerated with the most common adverse event being diarrhea, which
was mostly mild to moderate in nature. Ironwood intends to discontinue
development of IW-9179 for gastroparesis and focus on ongoing programs
in three key franchises: irritable bowel syndrome with
constipation/chronic idiopathic constipation, vascular and fibrotic
disease, and refractory gastroesophageal reflux disease.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (NASDAQ: IRWD) is a commercial biotechnology
company focused on creating medicines that make a difference for
patients, building value for our fellow shareholders, and empowering our
passionate team. We are advancing an innovative pipeline of medicines in
multiple areas of significant unmet need, including irritable bowel
syndrome with constipation (IBS-C)/chronic idiopathic constipation
(CIC), vascular and fibrotic diseases, and refractory gastroesophageal
reflux disease, among others. We discovered, developed and are
commercializing linaclotide, the U.S. branded prescription market leader
in the IBS-C/CIC category, and we are applying our proven R&D and
commercial capabilities to advance multiple internally-developed and
externally-accessed product opportunities. Ironwood was founded in 1998
and is headquartered in Cambridge, Mass. For more information, please
visit www.ironwoodpharma.com
or 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 statements about the top-line data from the Phase
IIa clinical study of IW-9179 in diabetic gastroparesis; the design of
the Phase IIa study and its impact on the results thereof; development
plans for IW-9179, including decisions regarding discontinuation of
development for gastroparesis and the drivers thereof; and the
advancement, development and prioritization of our product candidates.
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 nonclinical and clinical studies may not be
replicated in later studies; the risk that analyses of clinical data may
not produce the expected findings; the risk that patient populations are
not as presently estimated or that there is insufficient commercial
opportunity; efficacy, safety and tolerability of linaclotide and our
product candidates; decisions by regulatory authorities; the risk that
we may never get sufficient patent protection for linaclotide and our
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, linaclotide or our product candidates; and those
risks listed under the heading "Risk Factors" and elsewhere in
Ironwood's Annual Report on Form 10-K for the year ended December 31,
2015 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.
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their respective owners. All rights reserved.
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