– Data reinforce the impact of linaclotide on
symptoms of IBS-C and CIC –
– Additional studies highlight the burden of
these disorders on patients –
Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a global
GI-focused healthcare company, presented new data from four
scientific abstracts during the American College of
Gastroenterology (ACG) 2023 Annual Scientific Meeting and
Postgraduate Course. These data provide further insight into the
impact of linaclotide on symptoms of irritable bowel syndrome with
constipation (IBS-C) and chronic idiopathic constipation (CIC), as
well as the burden of these disorders on patients.
“IBS-C and CIC are complex disorders that involve more than just
constipation, and continued research into their persistent burden
promotes better understanding of the multiple needs among these
patients,” said Michael Shetzline, M.D., Ph.D., chief medical
officer, senior vice president and head of research and drug
development at Ironwood Pharmaceuticals. “The data presented at ACG
peel back the many layers of these disorders’ impact. While pain is
usually associated with IBS-C, it also can be experienced by those
with CIC and both patient groups can be affected by
anal/rectal-related adverse consequences. Ironwood is committed to
understanding the impact of linaclotide on the full spectrum of
symptoms in these disorders.”
Impact of Linaclotide in Patients with IBS-C and CIC
- A poster titled Effect of Menopausal Status Defined by Age on
Treatment Efficacy in Women with Irritable Bowel Syndrome with
Constipation: A Post Hoc Analysis of Pooled Phase 2b/3 Trials was
presented by Lin Chang, M.D., David Geffen School of Medicine at
UCLA, Los Angeles, CA. In this post-hoc analysis of efficacy data
from Phase 2b/3 trials, a numerically higher percentage of
responders were observed for abdominal pain and constipation, 30%
improvement in abdominal pain, and degree of relief of IBS symptoms
in patients aged >45 vs ≤45 years; adequate relief was also
significantly higher in patients aged >45. Comparing treatment
response within similar age groups, significant improvements were
observed in patients receiving linaclotide versus placebo for every
efficacy and responder endpoint assessed (all P<0.0001).
- A poster titled Linaclotide Improves Abdominal Symptoms over
Placebo in Patients with Chronic Idiopathic Constipation: A Pooled
Analysis was presented by Philip S. Schoenfeld, M.D.,
Gastroenterology Section, John D. Dingell Veterans Affairs Medical
Center, Detroit, MI. The post-hoc analysis showed that at 12 weeks
the patients with CIC receiving linaclotide had statistically
significant decreases in change from baseline (CFB) and % CFB for
abdominal pain, discomfort, and bloating compared to patients
receiving placebo (all P<0.0001). Significant improvements in
all three abdominal symptoms with linaclotide versus placebo were
seen starting at week 1 and sustained through week 12. A
significantly greater proportion of patients receiving linaclotide
were responders for improvements in abdominal pain, discomfort and
bloating versus those patients receiving placebo (all
P≤0.001).
- A poster titled Treatment Satisfaction and Quality of Life in
Patients with Irritable Bowel Syndrome with Constipation and
Chronic Idiopathic Constipation was presented by Brian Lacy,
Division of Gastroenterology and Hepatology, Mayo Clinic,
Jacksonville, FL. The analysis of data from a large, nationwide
survey of adults in the U.S. from August 2020 to December 2021
showed that participants taking prescription medications for IBS-C
and CIC were more likely to be satisfied with control of bowel or
abdominal symptoms than participants taking only over-the-counter
medication.
Burden of IBS-C and CIC
- A poster titled Burden of Anal/Rectal-Related Adverse
Consequences Associated with Chronic Straining Among Patients with
Irritable Bowel Syndrome and/or Constipation was presented by Kathy
Kosch, AbbVie Inc., North Chicago, IL. This retrospective cohort
study derived from health insurance claims found that non-D IBS and
CIC cases had a higher proportion of anal/rectal-related adverse
events versus controls, with the most common event being
hemorrhoids. Non-D-IBS and CIC cases had higher costs versus
controls on both a per-patient and a per-utilization basis.
About Linaclotide
LINZESS® is the #1 prescribed brand in the U.S. for the
treatment of adult patients with irritable bowel syndrome with
constipation (“IBS-C”) or chronic idiopathic constipation (“CIC”),
based on IQVIA data.
LINZESS is a once-daily capsule that helps relieve the abdominal
pain, constipation, and overall abdominal symptoms of bloating,
discomfort and pain associated with IBS-C, as well as the
constipation, infrequent stools, hard stools, straining, and
incomplete evacuation associated with CIC. LINZESS relieves
constipation in children and adolescents aged 6 to 17 years with
functional constipation. The recommended dose is 290 mcg for IBS-C
patients and 145 mcg for CIC patients, with a 72 mcg dose approved
for use in CIC depending on individual patient presentation or
tolerability. In children with functional constipation aged 6 to 17
years, the recommended dose is 72 mcg.
LINZESS is not a laxative; it is the first medicine approved by
the FDA in a class called GC-C agonists. LINZESS contains a peptide
called linaclotide that activates the GC-C receptor in the
intestine. Activation of GC-C is thought to result 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.
In the United States, Ironwood and AbbVie co-develop and
co-commercialize LINZESS for the treatment of adults with IBS-C or
CIC. In Europe, AbbVie 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
or CIC. Ironwood also has partnered with AstraZeneca for
development and commercialization of LINZESS in China, and with
AbbVie for development and commercialization of linaclotide in all
other territories worldwide.
LINZESS Important Safety Information
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) and functional constipation
(FC) in children and adolescents 6 to 17 years of age. It is not
known if LINZESS is safe and effective in children with FC less
than 6 years of age or in children with IBS-C less than 18 years of
age.
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF SERIOUS DEHYDRATION IN
PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE
LINZESS is contraindicated in patients
less than 2 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.
Contraindications
- LINZESS is contraindicated in patients less than 2 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
- LINZESS is contraindicated in patients less than 2 years of
age. In neonatal mice, linaclotide increased fluid secretion as a
consequence of age-dependent elevated guanylate cyclase (GC-C)
agonism, which was associated with increased mortality within the
first 24 hours due to dehydration. There was no age dependent trend
in GC-C intestinal expression in a clinical study of children 2 to
less than 18 years of age; however, there are insufficient data
available on GC-C intestinal expression in children less than 2
years of age to assess the risk of developing diarrhea and its
potentially serious consequences in these patients.
Diarrhea
- In adults, 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.
- In children and adolescents 6 to 17 years of age, diarrhea was
the most common adverse reaction in 72 mcg LINZESS-treated patients
in the FC double-blind placebo-controlled trial. Severe diarrhea
was reported in <1% of 72 mcg LINZESS treated 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 or CIC adult patients: diarrhea, abdominal pain,
flatulence, and abdominal distension.
- In FC pediatric patients: diarrhea.
Please see full Prescribing Information including Boxed Warning:
http://www.allergan.com/assets/pdf/linzess_pi
LINZESS® and CONSTELLA® are registered trademarks of Ironwood
Pharmaceuticals, Inc. Any other trademarks referred to in this
press release are the property of their respective owners. All
rights reserved.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (Nasdaq: IRWD), an S&P SmallCap
600® company, is a leading global gastrointestinal (GI) healthcare
company on a mission to advance the treatment of GI diseases and
redefine the standard of care for GI patients. We are pioneers in
the development of LINZESS® (linaclotide), the U.S. branded
prescription market leader for adults with irritable bowel syndrome
with constipation (IBS-C) or chronic idiopathic constipation (CIC).
LINZESS is also approved for the treatment of functional
constipation in pediatric patients ages 6-17 years-old. Ironwood is
also advancing apraglutide, a next-generation, long-acting
synthetic GLP-2 analog being developed for rare gastrointestinal
diseases, including short bowel syndrome with intestinal failure
(SBS-IF) as well as several earlier stage assets. Building upon our
history of GI innovation, we keep patients at the heart of our
R&D and commercialization efforts to reduce the burden of GI
diseases and address significant unmet needs.
Founded in 1998, Ironwood Pharmaceuticals is headquartered in
Boston, Massachusetts, and has additional operations in Basel,
Switzerland.
We routinely post information that may be important to investors
on our website at www.ironwoodpharma.com. In addition, follow us on
Twitter and on LinkedIn.
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 the impact
of linaclotide on symptoms of IBS-C and CIC, as well as the burden
of these disorders on patients. These forward-looking statements
speak only as of the date of this press release, and Ironwood
undertakes no obligation to update these forward-looking
statements. 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 the effectiveness of
development and commercialization efforts by us and our partners;
preclinical and clinical development, manufacturing and formulation
development of linaclotide and our product candidates; the risk
that clinical programs and studies may not progress or develop as
anticipated, including that studies are delayed or discontinued for
any reason, such as safety, tolerability, enrollment,
manufacturing, economic or other reasons; the risk that findings
from our completed nonclinical and clinical studies may not be
replicated in later studies; the risk that we or our partners are
unable to obtain, maintain or manufacture sufficient LINZESS,
apraglutide or our product candidates, or otherwise experience
difficulties with respect to supply or manufacturing; the efficacy,
safety and tolerability of linaclotide, apraglutide and our product
candidates; the risk that the therapeutic opportunities for
LINZESS, apraglutide or our product candidates are not as we
expect; decisions by regulatory and judicial authorities; the risk
we may never get additional patent protection for linaclotide,
apraglutide and other product candidates, that patents for
linaclotide, apraglutide or other products may not provide adequate
protection from competition, or that we are not able to
successfully protect such patents; outcomes in legal proceedings to
protect or enforce the patents relating to our products and product
candidates, including abbreviated new drug application litigation;
the risk that financial and operating results may differ from our
projections; developments in the intellectual property landscape;
challenges from and rights of competitors or potential competitors;
developments in accounting guidance or practice; Ironwood’s or
AbbVie’s accounting practices, including reporting and settlement
practices as between Ironwood and AbbVie; the risk that we are
unable to manage our expenses or cash use, or are unable to
commercialize our products as expected; and the risks listed under
the heading “Risk Factors” and elsewhere in our Annual Report on
Form 10-K for the fiscal year ended December 31, 2022, and in our
subsequent SEC filings.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231023571459/en/
Media:
Beth Calitri, 978-417-2031 bcalitri@ironwoodpharma.com
Investors:
Greg Martini, 617-374-5230 gmartini@ironwoodpharma.com
Matt Roache, 617-621-8395 mroache@ironwoodpharma.com
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