-Multiple Phase II Studies Expected to Initiate in 2016-
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Ironwood
Pharmaceuticals, Inc. (NASDAQ: IRWD) today announced positive
top-line data from a Phase Ia study of IW-1701, an investigational
soluble guanylate cyclase (sGC) stimulator from Ironwood's vascular and
fibrotic disease platform. In the study, IW-1701 demonstrated the
expected cardiovascular pharmacodynamic effects, proof of mechanism for
sGC stimulation, a dose range that was well tolerated in healthy
volunteers as a single dose, and a pharmacokinetic profile suitable for
once-daily dosing and consistent with distribution into tissues. The
totality of clinical and preclinical data generated to date supports
continued development of IW-1701, and Ironwood intends to initiate a
Phase Ib multiple ascending dose study in the first half of 2016, with
topline data from this study expected by the end of 2016.
"Soluble guanylate cyclase is part of a signaling pathway that regulates
blood flow, inflammation and fibrosis, which is why sGC stimulators
offer such a breadth of therapeutic potential in vascular and fibrotic
diseases 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," said Mark
Currie, Ph.D., chief scientific officer and president of research and
development at Ironwood. "Today's positive Phase Ia results with IW-1701
- along with our recent positive Phase Ia data with our other clinical
sGC stimulator IW-1973 - demonstrate that Ironwood's sGC stimulators
have attractive pharmacologic and pharmacokinetic profiles, providing
multiple opportunities to develop therapies that, if approved, can
address important unmet needs."
These IW-1701 Phase Ia data, along with Phase Ib data for IW-1973 and
IW-1701 expected later this year, will inform the selection of doses and
priority indications for the expected initiation of multiple Phase II
studies with Ironwood's sGC stimulators in 2016. IW-1701 and IW-1973
have distinct pharmacologic profiles and have the potential to produce
multiple blockbuster products for the company.
Similar to Ironwood's recently completed Phase Ia study of IW-1973, the
Phase Ia study of IW-1701 was designed as a randomized, double-blind,
placebo-controlled, single ascending dose study. The 24 healthy
volunteers enrolled were randomized 3:1 to receive a single dose of
IW-1701 or placebo administered once-daily via an oral capsule. Top-line
clinical data were consistent with preclinical findings and included
cardiovascular pharmacodynamic effects, dose-proportional
pharmacokinetics, and biomarker-based confirmation of target engagement.
No serious adverse events were reported. Reported adverse events were
consistent with the mechanism of action. Study results are expected to
be presented at a future medical conference.
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 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 design
and results of our clinical and preclinical studies of IW-1701 and
IW-1973 and the impact thereof, including the Phase Ia study of IW-1701
and the effects, tolerability, tissue distribution, suitability for once
daily dosing and proof of mechanism observed; the impact of data from
the Phase I studies for IW-1701 and IW-1973 on future development plans
for our sGC stimulators; the clinical programs for our sGC stimulators,
including the expected Phase Ib and II clinical studies, the goals and
design of such studies, the data to be generated from such studies and
the timing and impact thereof; the anticipated release of more data on
IW-1701 at medical conferences; the therapeutic opportunities for sGC
stimulators and the unmet need for such diseases; the blockbuster
potential of IW-1701 and IW-1973; and the design, breath, scope and
potential of our library of sGC stimulators, their pharmacological and
pharmacokinetic profiles, 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, but are not limited to, the risk that
we are unable to conduct the Phase Ib or 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, including with respect to doses and priority
indications; 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;
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 September 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160218005334/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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