CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Ironwood
Pharmaceuticals, Inc. (NASDAQ:IRWD), a commercial biotechnology
company, today announced that the company and its collaborators are
presenting clinical data for linaclotide at the World Congress of
Gastroenterology (WCOG) at the American College of Gastroenterology
(ACG), on October 13-18, 2017 in Orlando, Florida.
Linaclotide is a guanylate cyclase‐C (GC‐C) agonist that acts by a
mechanism pioneered by Ironwood scientists. Linaclotide is marketed in
the United States as LINZESS® and is the U.S. branded prescription
market leader for adults with Chronic Idiopathic Constipation (CIC) or
Irritable Bowel Syndrome with Constipation (IBS-C). It is also marketed
in Japan as LINZESS for the treatment of adults with IBS-C, and in
Europe as CONSTELLA® for the treatment of adults with moderate to severe
IBS-C. Linaclotide delayed release-1 (DR1) is an investigational drug
designed to provide targeted delivery of linaclotide to the distal small
intestine and colon, where it is believed that the majority of the
abdominal pain associated with IBS-C originates.
Researchers will present analyses of clinical data focusing on the
safety and tolerability of linaclotide in the treatment of CIC and
IBS-C, and on symptom improvement with linaclotide DR1 in IBS-C. An
additional presentation will focus on the effect of stool consistency on
bowel movement satisfaction with treatment of patients with IBS-C or
CIC. The data will be presented via poster presentations as follows:
Bowel Movement Satisfaction in Patients with IBS-C or CIC:
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Impact of Stool Consistency on Bowel Movement Satisfaction in IBS-C
or CIC Patients Treated With Linaclotide or Other Medications: Results
From the CONTOR Study (Abstract #P301), by Douglas C.A. Taylor,
M.B.A., Director, Health Economics and Outcomes Research, Ironwood
Pharmaceuticals, will be presented during a poster session on Sunday,
October 15, 3:30 to 7:00 p.m.
Symptom Improvement with Linaclotide DR1 in IBS-C:
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Effect of Linaclotide DR1, a Delayed-Release Formulation of
Linaclotide, in IBS-C Patients: Analysis of Symptom Improvement Using
Responder Radar Plots (Abstract #P1149), by William D. Chey, M.D.,
F.A.C.G. Professor of Medicine, Michigan Medicine, University of
Michigan, Ann Arbor, Michigan, will be presented during a poster
session on Monday, October 16, 10:30 a.m. to 4:00 p.m.
Pooled Analysis of Safety and Tolerability of Linaclotide for the
Treatment of CIC and IBS-C:
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Safety and Tolerability of Linaclotide for the Treatment of CIC and
IBS-C: A Pooled Analysis of Phase 3-3b Placebo-Controlled Trials in
North America (Abstract #P2020), by Judy Nee, M.D., Beth Israel
Deaconess Medical Center, Boston, Massachusetts, will be presented
during a poster session on Tuesday, October 17, 10:30 a.m. to 4:30 p.m.
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
for the treatment of hyperuricemia associated with gout in patients who
have not achieved target serum uric acid (sUA) levels with a medically
appropriate daily dose of a xanthine oxidase inhibitor (XOI) alone. We
are also advancing a pipeline of internally and externally generated
innovative product candidates in areas of significant unmet need,
including uncontrolled gastroesophageal reflux disease and vascular and
fibrotic diseases. 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.
About Linaclotide
Linaclotide is a guanylate cyclase‐C (GC‐C) agonist that binds to the
GC-C receptor locally, within the intestinal epithelium, and is thought
to work in two ways, based on nonclinical studies. Activation of GC-C
results in increased intestinal fluid secretion and accelerated transit,
as well as a decrease in the activity of pain-sensing nerves in the
intestine. The clinical relevance of the effect on pain fibers, which is
based on nonclinical studies, has not been established. Linaclotide is
marketed by Ironwood and Allergan plc in the United States as LINZESS®
and is indicated for the treatment of adults with irritable bowel
syndrome with constipation (IBS-C) or chronic idiopathic constipation
(CIC), with greater than 1.5 million unique patients in the United
States having filled more than 8 million linaclotide prescriptions since
launch, according to QuintilesIMS. In Europe, Allergan markets
linaclotide under the brand name CONSTELLA® for the treatment of adults
with moderate to severe IBS-C. In Japan, Ironwood's partner Astellas
markets linaclotide under the brand name LINZESS for the treatment of
adults with IBS-C. Ironwood also has partnered with AstraZeneca for
development and commercialization of linaclotide in China, Hong Kong and
Macau, and with Allergan for development and commercialization of
linaclotide in all other territories worldwide.
LINZESS INDICATIONS AND USAGE
LINZESS (linaclotide) is indicated in adults for the treatment of both
irritable bowel syndrome with constipation (IBS-C) and chronic
idiopathic constipation (CIC).
IMPORTANT SAFETY INFORMATION
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WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS
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LINZESS is contraindicated in patients less than 6 years of age.
In nonclinical studies in neonatal mice, administration of a
single, clinically relevant adult oral dose of linaclotide caused
deaths due to dehydration. Use of LINZESS should be avoided in
patients 6 years to less than 18 years of age. The safety and
effectiveness of LINZESS has not been established in patients less
than 18 years of age.
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Contraindications
LINZESS is contraindicated in patients less than 6 years of age due to
the risk of serious dehydration.
LINZESS is contraindicated in patients with known or suspected
mechanical gastrointestinal obstruction.
Warnings and Precautions
Pediatric Risk
LINZESS is contraindicated in patients less than 6 years of age. The
safety and effectiveness of LINZESS in patients less than 18 years of
age have not been established. In neonatal mice, linaclotide increased
fluid secretion as a consequence of GC-C agonism resulting in mortality
within the first 24 hours due to dehydration. Due to increased
intestinal expression of GC-C, patients less than 6 years of age may be
more likely than patients 6 years of age and older to develop severe
diarrhea and its potentially serious consequences.
Use of LINZESS should be avoided in pediatric patients 6 to less than 18
years of age. Although there were no deaths in older juvenile mice,
given the deaths in young juvenile mice and the lack of clinical safety
and efficacy data in pediatric patients, use of LINZESS should be
avoided in pediatric patients 6 years to less than 18 years of age.
Diarrhea
Diarrhea was the most common adverse reaction in LINZESS-treated
patients in the pooled IBS-C and CIC double-blind placebo-controlled
trials. The incidence of diarrhea was similar in the IBS-C and CIC
populations. Severe diarrhea was reported in 2% of 145 mcg and 290 mcg
LINZESS-treated patients, and in < 1% of 72 mcg LINZESS-treated CIC
patients. If severe diarrhea occurs, dosing should be suspended and the
patient rehydrated.
Common Adverse Reactions (incidence ≥2% and greater than placebo)
In IBS-C clinical trials: diarrhea (20% vs 3% placebo), abdominal pain
(7% vs 5%), flatulence (4% vs 2%), headache (4% vs 3%), viral
gastroenteritis (3% vs 1%) and abdominal distension (2% vs 1%).
In CIC trials of a 145 mcg dose: diarrhea (16% vs 5% placebo), abdominal
pain (7% vs 6%), flatulence (6% vs 5%), upper respiratory tract
infection (5% vs 4%), sinusitis (3% vs 2%) and abdominal distension (3%
vs 2%). In a CIC clinical trial of a 72 mcg dose: diarrhea (19% vs 7%
placebo) and abdominal distension (2% vs < 1%).
Please see full Prescribing Information: http://www.allergan.com/assets/pdf/linzess_pi
LINZESS® and CONSTELLA® are trademarks of Ironwood Pharmaceuticals, Inc.
Any other trademarks referred to in this press release are the property
of their respective owners. All rights reserved.
View source version on businesswire.com: http://www.businesswire.com/news/home/20171016005379/en/
Investor and Media Relations
Ironwood Pharmaceuticals
Meredith
Kaya, 617-374-5082
Senior Director, Investor Relations and
Corporate Communications
mkaya@ironwoodpharma.com
Source: Ironwood Pharmaceuticals, Inc.
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