– Data from pivotal Phase III STARS study in
short bowel syndrome with intestinal failure (SBS-IF) accepted as
late-breaker oral presentation on May 21 at 10:30 am ET –
– Findings from the STARS Nutrition Study in
SBS-IF will be highlighted in poster presentations –
– Additional posters will focus on linaclotide,
irritable bowel syndrome with constipation and functional
constipation –
Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a
GI-focused healthcare company, announced today that the company
will present new data from studies evaluating apraglutide in adults
with short bowel syndrome with intestinal failure (SBS-IF), a
condition in which patients are dependent on parenteral support
(PS), during the 2024 Digestive Disease Week® (DDW) meeting. DDW is
held from May 18-21, 2024, in Washington, D.C.
SBS-IF, a rare chronic debilitating malabsorptive condition in
which patients are dependent on PS, affects an estimated 18,000
adult patients in the U.S., Europe, and Japan. Apraglutide data
from the STARS Phase III trial, which evaluated the safety and
efficacy of once-weekly apraglutide in reducing PS dependency in
adult patients with SBS-IF, will be presented at DDW 2024 as a
late-breaker oral presentation. Ironwood announced topline data
from the STARS Phase III trial in February 2024.
The late-breaker presentation includes new apraglutide data from
the STARS Phase III trial. Based on these results, the company is
working to submit a new drug application (NDA) to the U.S. Food and
Drug Administration (FDA) and other regulatory filings for
apraglutide for use in adult patients with SBS who are dependent on
PS.
“Coming off our recently announced positive topline results from
STARS, we’re excited to share additional study findings that
underscore the importance of apraglutide as a potential once-weekly
GLP-2 analog for adult patients with SBS who are dependent on
parenteral support,” said Michael Shetzline, M.D., Ph.D., chief
medical officer, senior vice president and head of research and
drug development at Ironwood Pharmaceuticals. “We also look forward
to showcasing additional real-world insights related to our IBS-C
and FC linaclotide portfolio.”
In addition to the oral presentation, a series of four posters
will highlight findings across the apraglutide development program.
Also, three posters will spotlight data on linaclotide in adults
with irritable bowel syndrome with constipation (IBS-C),
disparities in IBS diagnosis, and real-world prescribing patterns
for pediatric patients with functional constipation (FC) and IBS-C.
A list of the data presentations is below.
Apraglutide in SBS-IF
- Efficacy and Safety of Apraglutide Once-Weekly in Patients with
Short Bowel Syndrome and Intestinal Failure (SBS-IF): Results from
the STARS Study - A Global Phase 3 Double-Blind, Randomized,
Placebo-Controlled Trial
- Oral presentation: May 21, 10:30 – 10:45 am ET.
- Changes in Bowel Morphology and Motility Assessed by MRI in
Patients with Short Bowel Syndrome Intestinal Failure (SBS-IF) and
Colon-In-Continuity Treated with Apraglutide
- Poster presentation number Su1946: May 19, 12:30 – 1:30 pm
ET.
- Parenteral Support Weaning, Clinical Benefit and Improved
Patient Reported Outcomes in Short Bowel Syndrome Intestinal
Failure (SBS-IF) Patients with Colon-In-Continuity Treated with the
Long-Acting Glucagon-Like Peptide-2 (GLP-2) Analog Apraglutide
- Poster presentation number Su1947: May 19, 12:30 – 1:30 pm
ET.
- Apraglutide Treatment in Short Bowel Syndrome with Intestinal
Failure (SBS-IF) and Colon-In-Continuity is Associated with
Increased Oral Intake and Improved Energy and Carbohydrate
Absorption at 48 Weeks
- Poster presentation number Su1948: May 19, 12:30 – 1:30 pm
ET.
- The Effect of Apraglutide on Gastric Emptying in Healthy
Individuals: A Phase 1 Randomized, Placebo-Controlled,
Double-Blind, Single-Center Trial
- Poster presentation number Su1949: May 19, 12:30 – 1:30 pm
ET.
Irritable Bowel Syndrome with Constipation and Functional
Constipation
- Real World Prescribing Patterns for Pediatric Patients with
Functional Constipation and Irritable Bowel Syndrome with
Constipation
- Poster presentation number Su2047: May 19, 12:30 – 1:30 pm
ET.
- Assessing US Healthcare Disparities in IBS Diagnosis: A
National Survey Analysis
- Poster presentation number Tu1027: May 21, 12:30 – 1:30 pm
ET.
- Efficacy, Safety, and Time to Response of Linaclotide in
Patients ≥65 with Irritable Bowel Syndrome with Constipation
- Poster presentation number Tu1653: May 21, 12:30 – 1:30 pm
ET.
About Apraglutide
Apraglutide is an investigational, synthetic GLP-2 analog being
developed for a range of rare gastrointestinal diseases where GLP-2
can play a central role in addressing disease pathophysiology,
including short bowel syndrome with intestinal failure (SBS-IF) and
Acute Graft-Versus-Host Disease (aGVHD).
About LINZESS® (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 for the treatment of both
irritable bowel syndrome with constipation (IBS-C) and chronic
idiopathic constipation (CIC) in adults 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:
https://www.rxabbvie.com/pdf/linzess_pi.pdf
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), which is the U.S.
branded prescription market leader for adults with irritable bowel
syndrome with constipation (IBS-C) or chronic idiopathic
constipation (CIC) and is also indicated 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, with a site 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
X 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
assessment of the data from the Phase III STARS clinical trial of
apraglutide; the safety, tolerability and efficacy of apraglutide;
the estimated adult population who suffer from SBS-IF in the U.S.,
Europe and Japan; Ironwood’s plan to submit an NDA for apraglutide
with the FDA for use in adult patients with SBS who are dependent
on PS; and the potential of apraglutide to be, if approved, a
once-weekly GLP-2 analog for adult patients with SBS who are
dependent on PS. 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 apraglutide; 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 completed nonclinical and clinical
studies may not be replicated in later studies; the risk that the
FDA may not approve our NDA submission; the risk of competition or
that new products may emerge that provide different or better
alternatives for treatment of the conditions that our products are
approved to treat; the risk that healthcare reform and other
governmental and private payor initiatives may have an adverse
effect upon or prevent our products’ or product candidates’
commercial success; the efficacy, safety and tolerability of our
product candidates; the risk that the commercial and therapeutic
opportunities for our product candidates are not as we expect; the
risk that we are unable to successfully partner with other
companies to develop and commercialize products or product
candidates; decisions by regulatory and judicial authorities; the
risk we may never get additional patent protection for our product
candidates, that patents for our products may not provide adequate
protection from competition, or that we are not able to
successfully protect such patents; the risk that the development of
apraglutide is not successful or that any of our product candidates
does not receive regulatory approval or is not successfully
commercialized; outcomes in legal proceedings to protect or enforce
the patents relating to our products and product candidates,
including abbreviated new drug application litigation; challenges
from and rights of competitors or potential competitors; and the
risks listed under the heading “Risk Factors” and elsewhere in our
Annual Report on Form 10-K for the year ended December 31, 2023,
and in our subsequent Securities and Exchange Commission
filings.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240501757166/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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