Home Heart Disease Treatment Ironwood Pharmaceuticals Announces FDA Fast Track Designation for Praliciguat for the Treatment of Heart Failure ...

Ironwood Pharmaceuticals Announces FDA Fast Track Designation for Praliciguat for the Treatment of Heart Failure ...

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CAMBRIDGE, Mass.--(BUSINESS WIRE)--Ironwood
Pharmaceuticals, Inc.
(NASDAQ: IRWD), a commercial biotech company,
today announced that the U.S. Food and Drug Administration (FDA) has
granted Fast Track Designation for praliciguat (IW-1973) for the
treatment of patients with heart failure with preserved ejection
fraction (HFpEF). Praliciguat is an investigational, orally administered
soluble guanylate cyclase (sGC) stimulator currently in Phase II
clinical trials.

“An ever-increasing number of people are suffering from HFpEF, a disease
characterized by exercise intolerance, frequent hospitalizations, and
increased risk of death, yet there are no approved treatment options,”
said Christopher Wright, M.D., Ph.D., senior vice president of global
development and chief development officer of Ironwood. “We believe
praliciguat has the potential to be a new treatment option for these
patients and are researching its ability to provide multi-dimensional
impact on this disease by increasing tissue blood flow and decreasing
cardiac vascular inflammation and fibrosis. The Fast Track Designation
underscores the seriousness of this disease and that praliciguat has
potential to address unmet needs in HFpEF. We look forward to working
closely with the FDA to rapidly progress the development of praliciguat
for the treatment of HFpEF.”

The FDA grants Fast Track Designation to facilitate the development and
expedite the review of drugs that have the potential to treat serious or
life-threatening diseases. A drug granted Fast Track Designation is
eligible for several benefits, including more frequent meetings with and
communications from the FDA and potentially for Rolling Review of the
New Drug Application (NDA) and Priority Review if relevant criteria are
met.1

Ironwood is currently enrolling patients in a randomized, double-blind,
placebo-controlled Phase II trial evaluating praliciguat for the
potential treatment of HFpEF. Ironwood expects to enroll approximately
175 patients into the Phase II trial, which is designed to evaluate the
safety and efficacy of praliciguat in patients with HFpEF. Topline data
from this study are expected in the second half of 2019. Further details
about the trial can be found at clinicaltrials.gov
using the identifier number NCT03254485.

About Heart Failure with Preserved Ejection Fraction

Heart failure with preserved ejection fraction (HFpEF) is a form of
heart failure that occurs when the left ventricle becomes stiff and its
ability to relax is reduced, causing the heart to be unable to fill with
blood sufficiently. HFpEF affects an increasing number of people in the
developed world, likely due to an increase in common risk factors such
as old age, hypertension, and obesity.

About Praliciguat

Praliciguat (IW-1973), an investigational, oral, once-daily soluble
guanylate cyclase (sGC) stimulator, is being studied in patients with
diabetic nephropathy and in patients with heart failure with preserved
ejection fraction (HFpEF). Diabetic nephropathy affects an estimated
eight million Americans and 20 to 40 percent of all diabetic patients
worldwide. It is the leading cause of end-stage renal disease. Currently
available products do not treat the underlying pathophysiology of the
disease or fully address the needs of this patient population. HFpEF
affects an estimated three million Americans and 40 to 70 percent of
heart failure patients worldwide. It is a highly symptomatic condition
with high rates of morbidity and mortality that can cause insufficient
delivery of oxygen to the tissues, fluid in the lungs and edema of the
extremities, causing patients to be short of breath and have compromised
exercise tolerance. There are no approved therapies to treat HFpEF.

Currently in Phase II development for diabetic nephropathy and for
HFpEF, praliciguat has the potential to address the underlying causes of
these devastating diseases by improving nitric oxide (NO) signaling,
which may improve vascular and metabolic function and decrease the
inflammatory and fibrotic consequences associated with these diseases.

About Ironwood's sGC Program

As a pioneering expert in cyclic GMP (cGMP), Ironwood is building on its
success with linaclotide, which stimulates guanylate cyclase-C in the
intestine, to develop a pipeline of soluble guanylate cyclase (sGC)
stimulators. sGC plays an important role in regulating diverse
physiological processes; dysregulation of sGC may play a role in
multiple serious diseases. Ironwood's sGC stimulators are believed to
harness the nitric oxide (NO)/sGC/cGMP pathway by working
synergistically with NO to improve blood flow and metabolism and
decrease inflammation and fibrosis.

Ironwood is advancing praliciguat (IW-1973) for the potential treatment
of diabetic nephropathy and of heart failure with preserved ejection
fraction (HFpEF). Olinciguat (IW-1701) is being developed for the
potential treatment of achalasia and of sickle cell disease. In
addition, Ironwood has a pipeline of other sGC stimulators in
pre-clinical development.

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 currently commercializing two innovative primary
care products: linaclotide, the U.S. branded prescription market leader
for adults with irritable bowel syndrome with constipation (IBS-C) or
chronic idiopathic constipation (CIC), and lesinurad, which is approved
to be taken with a xanthine oxidase inhibitor (XOI), or as a fixed-dose
combination with allopurinol, for the treatment of hyperuricemia
associated with gout. We are also advancing a pipeline of innovative
product candidates in areas of significant unmet need, including
persistent gastroesophageal reflux disease, diabetic nephropathy, heart
failure with preserved ejection fraction, achalasia and sickle cell
disease. 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.

Forward-Looking Statements

This press release contains forward-looking statements. Investors are
cautioned not to place undue reliance on these forward-looking
statements, including statements about Ironwood's sGC program and the
clinical program for praliciguat, including the design, size, and scope
of the Phase II clinical trial; the mechanism of action of praliciguat;
the size of the potential patient population and treatment options for
HFpEF; the data to be generated from the Phase II clinical trial and the
timing of such data; the cause of the disease and the symptoms suffered
by the potential patient population; and praliciguat as a potential
treatment for HFpEF. 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 the risk that we are unable to
enroll as many patients in the clinical study or complete the Phase II
clinical trial on the same timeline as we currently anticipate; the risk
that the data from the clinical trial may not be available when we
currently anticipate them or do not demonstrate the results we expect,
including with respect to efficacy, safety and tolerability; the risk
that the Phase II clinical trial needs to be discontinued for any
reason, including safety, enrollment, manufacturing or economic reasons;
the patient population is not as large as we presently estimate; the
effectiveness of development and commercialization efforts; 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; decisions by regulatory
authorities; the risk that we may never get sufficient patent protection
for praliciguat or that we are not able to successfully protect such
patents; the outcomes in legal proceedings to protect or enforce the
patents relating to praliciguat; 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 business or the praliciguat program; and
those risks listed under the heading "Risk Factors" and elsewhere in
Ironwood's Quarterly Report on Form 10-Q for the quarter ended June 30,
2018, 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.

1 “Fast Track.” US Food and Drug Administration. https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm.
Published January 4, 2018. Accessed September 12, 2018.

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