Ironwood Pharmaceuticals to Highlight Clinical & Preclinical Data for Praliciguat at the American Diabetes Association’s 78...
June 20 2018 - 8:00AM
Business Wire
- Praliciguat Phase IIa data to be featured in
an oral presentation -
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/
Ironwood Pharmaceuticals, Inc.Meredith Kaya, 617-374-5082Vice
President, Investor Relations and Corporate
Communicationsmkaya@ironwoodpharma.comorJessi Rennekamp,
617-374-5404Associate Director, Corporate
Communicationsjrennekamp@ironwoodpharma.com
Ironwood Pharmaceuticals (NASDAQ:IRWD)
Historical Stock Chart
From Mar 2024 to Apr 2024
Ironwood Pharmaceuticals (NASDAQ:IRWD)
Historical Stock Chart
From Apr 2023 to Apr 2024