- Data to be presented at American College of Cardiology, Association
for Research in Vision and Ophthalmology, and American Thoracic Society -
Ironwood
Pharmaceuticals, Inc. (NASDAQ: IRWD) today announced that the
company and its academic collaborators will present clinical and
preclinical data on several soluble guanylate cyclase (sGC) stimulators
from Ironwood’s vascular and fibrotic disease platform at multiple
upcoming scientific conferences. Currently, two of Ironwood’s
investigational sGC stimulators, IW‐1973 and IW‐1701, are in Phase I
studies, with multiple Phase II studies expected to initiate this year.
“The Ironwood team continues to leverage our pharmacologic expertise in
guanylate cyclases to explore innovative potential applications of sGC
stimulators across a broad range of vascular and fibrotic diseases,”
said Mark Currie, Ph.D., chief scientific officer and president of
research and development at Ironwood. “We believe the critical role of
the sGC pathway in regulating blood flow, inflammation and fibrosis
provides the opportunity to develop multiple products for significant
unmet needs, and we look forward to advancing our first clinical
candidates into multiple Phase II studies expected later this year.”
The data will be presented as follows:
First-in-Human Single-Ascending-Dose Study of IW-1973, a New Soluble
Guanylate Cyclase Stimulator (1205M-05), by John Hanrahan, M.D.,
M.P.H., senior director of clinical research at Ironwood
Pharmaceuticals, Inc., et al., will be presented at the American College
of Cardiology 65th Annual Scientific Sessions taking place
April 2-4, 2016, in Chicago. The oral moderated ePoster presentation
will take place on Sunday, April 3, 2016, 1:00-1:15 p.m. Central Time in
the Heart Failure and Cardiomyopathies Moderated Poster Theater, South
Hall A1 during the Novel Therapies in Heart Failure poster session.
The Soluble Guanylate Cyclase Stimulator IWP-953 Increases
Conventional Outflow Facility in Mouse Eyes (3010 - A0359), by Pei
Ge, Ph.D., senior scientist at Ironwood Pharmaceuticals, Inc., et al.,
will be presented at the Association for Research in
Vision and Ophthalmology Annual Meeting taking place May 1-5, 2016, in
Seattle. The presentation will take place on Tuesday, May 3, 2016,
8:30-10:15 a.m. Pacific Time during the Glaucoma Clinical Studies and
Pharmacology poster session.
Two additional posters featuring preclinical data on sGC stimulators
from Ironwood’s vascular and fibrotic disease platform will be presented
at the American Thoracic Society International Conference taking place
May 13-18, 2016, in San Francisco. The titles of these posters remain
embargoed until abstracts are released.
About Ironwood’s sGC Platform
The enzyme soluble guanylate cyclase (sGC) plays a central role in
physiological control of blood flow, inflammation, and fibrosis.
Modulating the sGC signaling pathway may have beneficial effects in
multiple vascular and fibrotic diseases with high unmet need, such as
congestive heart failure and diabetic nephropathy, as well as certain
orphan diseases such as pulmonary arterial hypertension, Duchenne
muscular dystrophy and achalasia, among others. Ironwood established its
expertise in guanylate cyclases through the discovery and development of
linaclotide, a guanylate cyclase C (GC‐C) agonist. Stimulation of sGC is
a clinically validated approach, and Ironwood has discovered a diverse
library of sGC stimulators. Ironwood’s investigational sGC stimulators
IW‐1973 and IW‐1701 are in Phase I studies with multiple Phase II
studies expected to initiate in 2016.
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 clinical programs for our sGC
stimulators, including the expected Phase II clinical studies; the
anticipated presentation of data on IW-1973 and IWP-953 at scientific
conferences; the role of and therapeutic opportunities for sGC
stimulators and the unmet need for such diseases; and the design,
breath, scope and potential of our library of sGC stimulators, and our
development plans and activities with respect thereto. 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
the risk that we are unable to conduct the Phase II clinical
studies for IW-1701 or IW-1973 on the same timelines or with the same
results as we currently anticipate, or we are otherwise unable to
effectively execute on the clinical programs for our sGC stimulators;
the risk that the data from such clinical studies are not available when
we currently anticipate them or do not demonstrate the results or
provide the information we expect; 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 previous non-clinical or clinical studies do not support the data
from future 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 competition and future business
decisions made by us and our competitors or potential competitors; 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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