-Praliciguat Phase IIa data to be featured in an oral
presentation -
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun. 20, 2018--
Ironwood
Pharmaceuticals, Inc. (NASDAQ: IRWD), a commercial biotechnology
company, today announced that the company will present clinical and
preclinical data for the company’s soluble guanylate cyclase (sGC)
stimulator praliciguat (IW-1973) during the American Diabetes
Association’s (ADA) 78th Scientific Sessions in Orlando,
Fla., June 22 through June 26, 2018. Praliciguat is currently being
studied in Phase II clinical trials in patients with diabetic
nephropathy and in patients with heart failure with preserved ejection
fraction (HFpEF).
Data from a Phase IIa 14-day study of praliciguat in patients with
diabetes and hypertension will be featured as an oral presentation
during the Emerging Targets for Diabetes Treatment session, presented by
John P. Hanrahan, M.D., M.P.H., of Ironwood. In addition, a Phase IIa
rapid dose escalation study of praliciguat in patients with diabetes and
hypertension will be presented during a poster session. Finally, new
data will be presented in a moderated poster discussion on praliciguat’s
effect on glucose tolerance, insulin sensitivity and triglycerides in a
preclinical diet-induced obesity model.
sGC plays an important role in regulating many critical physiological
processes; therefore dysregulation of sGC may play a role in multiple
serious diseases. Ironwood’s sGC stimulators, including praliciguat, are
believed to harness the nitric oxide/sGC/cyclic guanosine monophosphate
(NO/sGC/cGMP) pathway by working synergistically with NO to improve
blood flow and metabolism and decrease inflammation and fibrosis.
Praliciguat has the potential to address the underlying causes of
devastating diseases such as diabetic nephropathy and HFpEF by improving
NO signaling, which may improve vascular and metabolic function and
decrease the inflammatory and fibrotic consequences associated with
these diseases.
The data will be presented as follows:
Oral Presentation
- Fourteen-Day Study of Praliciguat, a Soluble Guanylate Cyclase
Stimulator, in Patients with Diabetes and Hypertension (oral
presentation 74-OR), by John P. Hanrahan, M.D., M.P.H., Ironwood
Pharmaceuticals, Inc., Cambridge, MA, will be presented during the
Emerging Targets for Diabetes Treatment session on Saturday, June 23,
8:30 a.m. to 8:45 a.m., in Room W304E-H of the Orange County
Convention Center.
Poster Sessions
- Praliciguat, a Clinical-Stage sGC Stimulator, Improved Glucose
Tolerance and Insulin Sensitivity and Lowered Triglycerides in a Mouse
Diet-Induced Obesity Model (moderated poster discussion and poster
session 1886-P), by Chad Schwartzkopf M.S., Ironwood Pharmaceuticals,
Inc., Cambridge, MA, will be presented at the Integrated Physiology of
Macronutrient Metabolism and Food Intake session on Saturday, June 23,
12:30 to 1:30 p.m., in the poster hall of the Orange County Convention
Center and at the General Poster Session on Monday, June 25, noon to
1:00 p.m., in the poster hall of the Orange County Convention Center.
- Rapid Dose Escalation Study of Praliciguat, a Soluble Guanylate
Cyclase Stimulator, in Patients with Diabetes and Hypertension (poster
session 1207-P), by Albert Profy, Ph.D., Ironwood Pharmaceuticals,
Inc., Cambridge, MA, will be presented at the General Poster Session
on Sunday, June 24, noon to 1:00 p.m., in the poster hall of the
Orange County Convention Center.
About Praliciguat
Praliciguat (IW-1973), an 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 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; the mechanism of action of
praliciguat; prevalence; and praliciguat as a potential treatment for
diabetic nephropathy and 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
preclinical and clinical development, manufacturing and formulation
development; the risk that future clinical studies need to be
discontinued for any reason, including safety, tolerability, enrollment,
manufacturing or economic reasons; the risk that findings from our
completed nonclinical and clinical studies may not be replicated in
later studies; efficacy, safety and tolerability of praliciguat; the
risk that the therapeutic opportunities for praliciguat are not as we
expect;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 March 31, 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180620005264/en/
Source: Ironwood Pharmaceuticals, Inc.
Ironwood Pharmaceuticals, Inc.
Meredith Kaya, 617-374-5082
Vice
President, Investor Relations and Corporate Communications
mkaya@ironwoodpharma.com
or
Jessi
Rennekamp, 617-374-5404
Associate Director, Corporate Communications
jrennekamp@ironwoodpharma.com