|Ironwood Pharmaceuticals Announces FDA Fast Track Designation for Praliciguat for the Treatment of Heart Failure with Preserved Ejection Fraction (HFpEF)|
– Praliciguat Phase II trial in HFpEF continues to enroll patients with topline data expected in the second half of 2019 –
“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,”
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.
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.
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
1 “Fast Track.”
Ironwood Pharmaceuticals, Inc.
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