- Oral Presentation of IW-3718 rGERD Data, As Well As Post-Hoc
Analysis of Linaclotide Sustained Response in CIC and Patient Insights
on Constipation -
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Ironwood
Pharmaceuticals, Inc. (NASDAQ: IRWD) today announced a series of
oral and poster presentations at the American College of
Gastroenterology 2015 Scientific Meeting in Honolulu, HI, October 16 to
21, 2015. The oral presentations include data from a Phase IIa study of
IW-3718 indicating that this investigational drug improved heartburn and
certain other symptoms associated with refractory gastroesophageal
reflux disease (GERD). A second oral presentation suggests that certain
patients suffering from chronic constipation may be at a higher risk of
developing serious GI complications.
The poster presentations include a post-hoc analysis reviewing the
sustainability of the response of linaclotide in patients with chronic
idiopathic constipation (CIC), as well as post-hoc analyses regarding
patient attitudes about treatment with linaclotide and treatment with
other therapies.
The titles and scheduled times of the presentations are as follows:
Results of Phase IIa Study in Patients with Refractory GERD (Oral
Presentation):
IW-3718, a Novel Gastric-Retentive Bile Acid Sequestrant, Improved
Symptoms of Refractory GERD in a Double-Blind, Placebo-Controlled Phase
2a Study (paper #58) to be presented during Plenary Session 1:
Esophagus / Endoscopy on Wednesday, Oct. 21, 2015, 1:30 p.m. to
1:40 pm (Eastern Time), by Michael Vaezi, M.D., Ph.D., M.S., Clinical
Director, Division of Gastroenterology, and Director of the Center for
Swallowing and Esophageal Disorders at Vanderbilt University Medical
Center.
Serious GI Complications Associated with Chronic Constipation (Oral
Presentation):
Association of Chronic Constipation with Gastrointestinal
Complications in Younger Patients (paper #40) to be presented during
the Colon/Functional Bowel Disorder Plenary Session on Tuesday, Oct. 20,
2015, 6:30 p.m. to 6:40 p.m. (Eastern Time), by Lauren B. Gerson, M.D.,
Board-Certified Gastroenterologist, Division of Gastroenterology,
California Pacific Medical Center. This presentation received ACG's
designation as "Most Newsworthy."
Patient Insights into Chronic Idiopathic Constipation Treatments
(Poster Presentations):
Patients' Use of and Experience with Medications for Management of
Symptoms of Chronic Constipation (poster P1724), to be presented on
Tuesday, Oct. 20, 2015, 3:30 p.m. to 9:30 p.m. (Eastern Time), by
William Spalding, Director, Health Economics & Outcomes Research at
Ironwood Pharmaceuticals, Inc. This poster received ACG's designation as
"Most Newsworthy."
Patient Attitudes Regarding Treatment Satisfaction and Bowel Movement
Confidence and Predictability: A Post-Hoc Comparison of Study Treatment
and Prior Medication Use Based on a Phase 3b Trial of Linaclotide in CIC
(poster P314), which was presented on Sunday, Oct. 18, 2015, by Douglas
Taylor, Director, Health Economics & Outcomes Research at Ironwood
Pharmaceuticals, Inc.
Treatment Satisfaction Among Patients With Constipation-Related Bowel
and Abdominal Symptoms: Results From the CONTOR Study (poster P542),
which was presented on Sunday, Oct. 18, 2015, by Douglas Taylor,
Director, Health Economics & Outcomes Research at Ironwood
Pharmaceuticals, Inc.
Characteristics Associated With Probiotic Use Among Patients
Experiencing Constipation-Related Symptoms: Results From the CONTOR
Study (poster P548), which was presented on Sunday, Oct. 18, 2015,
by Brennan Spiegel, M.D., M.S.H.S., Cedars-Sinai Health System, Los
Angeles, CA.
Sustained Response of Linaclotide in Chronic Idiopathic Constipation
Patients (Poster Presentation):
Sustainability of Linaclotide Response in Chronic Idiopathic
Constipation Patients: a Post-hoc Pooled Analysis of Two Phase 3 Trials
(poster P1012), to be presented on Monday, Oct. 19, 2015, 4:00 p.m. to
9:30 p.m. (Eastern Time), by Bernard Lavins, Senior Director, Clinical
Research at Ironwood Pharmaceuticals, Inc.
About Linaclotide
Linaclotide is a guanylate cyclase‐C (GC‐C) agonist that is thought to
work in two ways based on nonclinical studies. Linaclotide binds to the
GC-C receptor locally, within the intestinal epithelium. Activation of
GC-C results in increased intestinal fluid secretion and accelerated
transit and 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 Actavis 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). Linaclotide is marketed by Almirall, S.A. for the treatment of
adults with moderate to severe IBS-C in Europe under the brand name
CONSTELLA®. Ironwood also has partnered with Astellas Pharma
Inc. for development and commercialization of linaclotide in Japan and
with AstraZeneca for development and commercialization in China.
LINZESS and CONSTELLA are trademarks owned by Ironwood Pharmaceuticals,
Inc. Any other trademarks referred to in this press release are the
property of their respective owners. All rights reserved.
LINZESS Important Safety Information
|
WARNING: PEDIATRIC RISK
|
LINZESS is contraindicated in pediatric patients under 6 years of
age. In nonclinical studies, administration of a single, clinically
relevant adult oral dose of linaclotide caused deaths due to
dehydration in young juvenile mice. Use of LINZESS should be avoided
in pediatric patients 6 through 17 years of age. The safety and
efficacy of LINZESS has not been established in pediatric patients
under 18 years of age.
|
Contraindications
-
LINZESS is contraindicated in pediatric patients under 6 years of age.
-
LINZESS is contraindicated in patients with known or suspected
mechanical gastrointestinal obstruction.
Warnings and Precautions
Pediatric Risk
-
LINZESS is contraindicated in children under 6 years of age. The
safety and effectiveness of LINZESS in pediatric patients under 18
years of age have not been established. In neonatal mice, increased
fluid secretion as a consequence of GC-C agonism resulted in mortality
within the first 24 hours due to dehydration. Due to increased
intestinal expression of GC-C, children under 6 years of age may be
more likely than older children and adults to develop significant
diarrhea and its potentially serious consequences.
-
Use of LINZESS should be avoided in pediatric patients 6 through 17
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 through 17 years of age.
Diarrhea
-
Diarrhea was the most common adverse reaction of LINZESS-treated
patients in the pooled IBS-C and CIC double-blind placebo-controlled
trials. Severe diarrhea was reported in 2% of LINZESS-treated
patients. The incidence of diarrhea was similar in the IBS-C and CIC
populations.
-
Patients should be instructed to stop LINZESS if severe diarrhea
occurs and to contact their healthcare provider. The healthcare
provider should consider dose suspension and rehydration.
Adverse Reactions
-
In IBS-C clinical trials, the most common adverse reactions in
LINZESS-treated patients (incidence ≥2% and greater than placebo) were
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 clinical trials, the most common adverse reactions in
LINZESS-treated patients (incidence ≥2% and greater than placebo) were
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%).
Please see full Prescribing Information including Boxed Warning: http://www.frx.com/pi/linzess_pi.pdf.
About IBS-C and CIC
While estimates vary, as many as 13 million adults in the U.S. may
suffer from IBS-C, and as many as 35 million may suffer from CIC.
Results derived from responses to a web based survey commissioned by
Forest Pharmaceuticals, now a member of Allergan plc, and Ironwood
Pharmaceuticals suggest that only about half of adult IBS-C sufferers
are medically diagnosed, and only about 12 percent of adult CIC
sufferers are medically diagnosed. Hallmark symptoms associated with
IBS-C include abdominal pain and constipation. Symptoms associated with
CIC may include constipation, hard or lumpy stools, infrequent stools,
and incomplete evacuation (not completely emptying the bowels). There
are few available prescription treatment options for these conditions.
About IW-3718
IW-3718 is a novel, gastric retentive formulation of a bile acid
sequestrant, developed by Ironwood using the proprietary Acuform® drug
delivery technology licensed from Depomed, Inc. IW-3718 is designed to
deliver the bile acid sequestrant to the desired sites of action -
specifically the stomach and duodenum (upper small intestine) - over an
extended period of time. Data from non-clinical studies support the
extended release profile of IW-3718.
About Refractory Gastroesophageal Reflux Disease (GERD)
An estimated 8 million Americans suffer from refractory gastroesophageal
reflux disease (GERD), experiencing continued symptoms such as heartburn
and regurgitation despite receiving the current standard of care
treatment with a proton pump inhibitor (PPI) to suppress stomach acid
production. There are a limited number of FDA-approved treatment options
for these patients. Research suggests reflux of bile from the intestine
into the stomach and esophagus may play a role in the ongoing symptoms
of refractory GERD patients.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (NASDAQ: IRWD) is focused on creating medicines
that make a difference for patients, building value to earn the
continued support of our fellow shareholders, and empowering our team to
passionately pursue excellence. We discovered, developed and are
commercializing linaclotide, which is approved in the United States and
a number of other countries. Our pipeline priorities include exploring
further opportunities for linaclotide, as well as leveraging our
therapeutic expertise in gastrointestinal disorders and our
pharmacologic expertise in guanylate cyclases to address patient needs
across the upper and lower gastrointestinal tract. Ironwood was founded
in 1998 and is headquartered in Cambridge, Mass. Connect with us at www.ironwoodpharma.com
or on Twitter at www.twitter.com/ironwoodpharma;
information that may be important to investors will be routinely posted
in both these locations.
All data are embargoed until October 19, 2015 at 8 a.m. (Eastern Time)
per ACG policy.
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Ironwood Pharmaceuticals, Inc.
Media Relations
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Morrison, 617-374-5095
[email protected]
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Source: Ironwood Pharmaceuticals, Inc.
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