Ironwood Pharmaceuticals to Highlight Clinical and Preclinical Data for Praliciguat at the American Diabetes
Association’s 78 th Scientific Sessions
- 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.
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
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