CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Ironwood
Pharmaceuticals, Inc. (NASDAQ:IRWD) announced today positive
top-line data from a Phase I study of IW-1973, its lead investigational
soluble guanylate cyclase (sGC) stimulator. In the study, IW-1973
demonstrated cardiovascular pharmacodynamic effects, extensive tissue
distribution, proof of mechanism for sGC stimulation, and a dose range
that was well tolerated in healthy volunteers. The totality of clinical
and preclinical data generated to date strongly support continued
development of IW-1973 as a potential once-daily oral therapy.
Ironwood intends to initiate a Phase Ib multiple ascending dose study of
IW-1973 in the fourth quarter of 2015. This study will inform the
selection of doses and priority indications for the Phase II program,
which will focus on areas with the highest unmet need and optimal path
to market. Ironwood intends to initiate at least two Phase II proof of
concept studies for IW-1973 in 2016.
"Soluble guanylate cyclase is a fundamental regulator of blood flow,
inflammation and fibrosis that is found in a wide range of human tissues
- this is why sGC stimulators offer such breadth of therapeutic
potential in cardiovascular disease, fibrosis, muscular dystrophy and
other disorders," said Mark Currie, Ph.D., chief scientific officer and
president of research and development at Ironwood. "We look forward to
leveraging our established expertise in guanylate cyclases to
investigate how the unique properties of IW-1973 observed thus far, such
as distribution into target tissues, may allow us to expand the
potential of the sGC stimulator class in cardiovascular and other
serious diseases."
The randomized, double-blind, placebo-controlled, single ascending dose
Phase I study enrolled 46 healthy volunteers. Participants were
randomized 3:1 to receive a single dose of IW-1973 or placebo
administered via an oral capsule. Top-line clinical data were consistent
with preclinical findings and included cardiovascular pharmacodynamic
effects, dose-proportional pharmacokinetics, biomarker-based
confirmation of target engagement, and evidence of extensive
distribution to tissues. No serious adverse events were reported.
Reported adverse events were consistent with the mechanism of action.
Data from clinical and preclinical studies of IW-1973 are expected to be
presented at a future medical conference.
About IW-1973 and Ironwood's sGC Platform
IW-1973 is the first clinical compound in Ironwood's novel chemical
series of pharmacologically distinct soluble guanylate cyclase (sGC)
stimulators. IW-1973 is expected to advance into a Phase Ib multiple
ascending dose study in the fourth quarter of 2015. Ironwood's second
sGC stimulator, IW-1701, is expected to begin a Phase I study also in
the fourth quarter of 2015.
The stimulation of sGC is a pharmacologically validated approach with
broad therapeutic potential. Found throughout the body, sGC is an enzyme
that is activated by the key regulator nitric oxide (NO) and modulates
levels of the second messenger cyclic guanosine monophosphate (cGMP), a
signaling molecule that regulates fluid homeostasis, blood flow,
inflammation and fibrosis. As fundamental regulators of such core
physiological processes, sGC modulators may be relevant in the treatment
of a broad range of diseases including cardiovascular diseases such as
pulmonary arterial hypertension and congestive heart failure, as well as
fibrosis, muscular dystrophy, and other disorders. Ironwood established
its expertise in the cGMP signaling pathway through the discovery and
development of linaclotide, a guanylate cyclase C (GC-C) agonist that
also modulates cGMP; the company has leveraged its GC-C expertise to
discover and patent its broad library of sGC stimulators.
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 clinical
program for IW-1973, including the timing of the expected Phase Ib and
II clinical studies, the goals of those studies and the anticipated
release of more data on IW-1973 at scientific conferences; the study's
impact on future development plans for sGC; the therapeutic
opportunities for sGC stimulators; the design, breath, scope and
potential of our library of sGC stimulators, their pharmacological
differentiation, and our development plans and activities with respect
thereto, including the timing of the expected Phase I clinical study for
IW-1701; the results of our preclinical clinical studies of IW-1973 and
our other sGC stimulators and the impact thereof; and the breath and
strength of the intellectual property for IW-1973 and our other sGC
stimulators. 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 the Phase Ib or II clinical studies for IW-1973 on
the same timelines or with the same goals as we currently anticipate, or
we are otherwise unable to effectively execute on our clinical program
for IW-1973; the risk that the data from future clinical studies for
IW-1973 are not available when we currently anticipate them or do not
demonstrate the results we expect, including with respect to safety,
pharmacokinetic profile or pharmacodynamic effects; the risk that we are
not able to publish data on our sGC program on the timeline or through
the media that we currently anticipate; the risk that future clinical
studies need to be discontinued for any reason, including safety,
tolerability, enrollment, manufacturing or economic reasons; the risk
that the data from non-clinical studies do not support the data from our
clinical study; the risk that we are not able to initiate the Phase I
clinical study for IW-1701 on the same timeline as we currently
anticipate; the risk that the therapeutic opportunities for sGC
stimulators and the potential for our library of sGC stimulators is not
as we expect; those related to decisions made by regulatory authorities;
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-1973 and our other sGC stimulators;
and those risks related to competition and future business decisions
made by us and our competitors or potential competitors. Applicable
risks also include those that are listed in Ironwood's Quarterly Report
on Form 10-Q for the quarter ended March 31, 2015, 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. 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150722005424/en/
Ironwood Pharmaceuticals, Inc.
Media Relations
Trista
Morrison, 617-374-5095
Director, Corporate Communications
tmorrison@ironwoodpharma.com
or
Investor
Relations
Meredith Kaya, 617-374-5082
Director, Investor
Relations
mkaya@ironwoodpharma.com
Source: Ironwood Pharmaceuticals, Inc.
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