Ironwood
Pharmaceuticals, Inc. (NASDAQ: IRWD) today announced the initiation
of a Phase Ib clinical study of IW-1973 and a Phase Ia clinical study of
IW-1701, both of which are investigational soluble guanylate cyclase
(sGC) stimulators from within a broad, pharmacologically-distinct
library of sGC compounds discovered by Ironwood. Data from the Phase Ia
study with IW-1701 are expected in the first half of 2016 and data from
the Phase Ib study with IW-1973 are expected in the second half of 2016;
these data are expected to inform the selection of doses and priority
indications for the planned Phase II sGC program, which will focus on
diseases with the highest unmet need and optimal path to market.
“Soluble guanylate cyclase is a fundamental regulator of blood flow,
inflammation and fibrosis, which endows sGC stimulators with broad
therapeutic potential in cardiovascular diseases, fibrotic diseases,
muscular dystrophy and other disorders,” said Mark Currie, Ph.D., chief
scientific officer and president of research and development at
Ironwood. “Ironwood has developed significant pharmacologic expertise in
guanylate cyclase pathways through our discovery of the GC-C agonist,
linaclotide, and we have applied this GC expertise to discover multiple
promising sGC stimulators.”
The Phase Ib clinical study of IW-1973 includes two stages: an
open-label, single dose, crossover stage and a randomized, double-blind,
placebo-controlled, multiple-ascending-dose stage. The study is designed
to assess the safety, tolerability, pharmacokinetic profile and
pharmacodynamic effects of IW-1973 repeat-doses administered orally to
healthy subjects. The Phase Ia clinical study of IW-1701 is a
randomized, double-blind, placebo-controlled, single-ascending-dose
study that will evaluate the safety, tolerability, pharmacokinetic
profile and pharmacodynamic effects of IW-1701 administered orally to
healthy subjects.
About Ironwood’s sGC Platform
IW-1973 and IW-1701 are investigational clinical compounds from
Ironwood’s library of pharmacologically distinct soluble guanylate
cyclase (sGC) stimulators. The stimulation of sGC is a clinically
validated approach with broad therapeutic potential. Found throughout
the body, sGC is an enzyme that is activated by the key regulator nitric
oxide (NO) to increase levels of the second messenger cyclic guanosine
monophosphate (cGMP), a signaling molecule that regulates blood flow,
inflammation and fibrosis. As fundamental regulators of such core
physiological processes, sGC stimulators 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 fibrotic diseases, 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 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.
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
programs for IW-1973 and IW-1701, including the design of the Phase I
studies and the completion thereof; the data to be generated from these
Phase I studies, the timing that these data are expected to be available
and the impact thereof on future development plans for our sGC program;
the focus of our planned sGC Phase II clinical program and the goals
thereof; the therapeutic opportunities for sGC stimulators; the design,
breath, scope and potential of our library of sGC stimulators, their
pharmacological distinctness, and our development plans and activities
with respect thereto, including the diseases and dosing schedules we
intend to pursue; and the results of our clinical and preclinical
studies of IW-1973 and our preclinical studies of IW-1701 and our other
sGC stimulators and the impact thereof. 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 complete the Phase I clinical studies for
IW-1973 and IW-1701 on the same timelines or with the same results as we
currently anticipate, or we are otherwise unable to effectively execute
on our sGC clinical program; the risk that the data from such clinical
studies are not available when we currently anticipate them or do not
demonstrate the results we expect, including with respect to safety,
tolerability, pharmacokinetic profile or pharmacodynamic effects; the
risk that the Phase I 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 or previous
clinical studies do not support the data from these clinical studies;
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, IW-1701 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 June 30, 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.
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