– Data show approximately 50% reduction of
parenteral support (PS) volume –
– 100% of patients were clinical responders
–
– 78% of patients achieved one or more days off
PS –
– Results support apraglutide as a potentially
best-in-class glucagon-like peptide-2 (GLP-2) analog for the
spectrum of patients with SBS-IF –
Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a global
GI-focused healthcare company, presented positive final data from
the company’s Phase II STARS Nutrition program during United
European Gastroenterology (UEG) Week. This multicenter study of
nine patients was designed to evaluate the safety,
pharmacokinetics, and efficacy of apraglutide, an investigational
next-generation, long-acting synthetic GLP-2 analog, on intestinal
absorption in adult patients who have Short Bowel Syndrome with
Intestinal Failure (SBS-IF) and Colon-in-Continuity (CIC). Positive
interim results from this study were first announced in October
2022.
The data from STARS Nutrition were featured at UEG Week during a
late-breaker oral presentation titled “The Long-Acting GLP-2 Analog
Apraglutide Provides Clinical Benefit For Patients With Short Bowel
Syndrome With Intestinal Failure And Colon In Continuity At 52
Weeks.” The presentation highlighted that apraglutide had an
acceptable safety profile, which was the primary study objective,
and that apraglutide improved intestinal absorption as indicated by
50% parenteral support (PS) volume and energy content decrease,
resulting in one or more days off PS. PS reduction was observed as
early as week four and was maintained until the end of the study.
Seventy-eight percent (78%) of patients gained one or more days off
PS with all patients achieving clinical response.
SBS-IF is a severe organ failure condition due to a reduction in
intestinal function below the minimum necessary for nutrient and
fluid absorption, leading to dependence on life-long PS to maintain
health, growth, and survival. The most severe cases require PS
(including parenteral nutrition and/or intravenous fluid) infusions
for up to 10 to 15 hours per day. An estimated 17,000 people are
thought to suffer from SBS-IF in the U.S. and Europe. Patients with
CIC who have a preserved colon with the remnant small intestine,
represent over 55% of the SBS-IF population with a large unmet
need. STARS Nutrition study is the first-ever study designed to
evaluate the clinical benefit of a GLP-2 analog specifically in
patients with SBS-IF with CIC.
“In order to secure adequate nutrition and hydration – the
fundamental elements of survival – people with SBS-IF-CIC endure a
significant impact on quality of life and run the risk of severe
complications such as infection,” said Tim Vanuytsel, M.D., Ph.D.,
gastroenterologist, Co-Chair of the Leuven Intestinal Failure and
Transplantation Center and lead investigator. “These data are a
strong testament to the durability of the effect of apraglutide on
improving intestinal absorption and reducing PS dependency in these
patients, and reinforce the interim results announced last year.
The STARS Nutrition study with apraglutide represents a significant
advance in understanding GLP-2 and how we can help all patients
with SBS-IF, including those with colon in continuity. The benefits
observed here could have a major impact on clinical care and
improving patient's quality of life if confirmed in the ongoing
STARS pivotal trial.”
The study showed that PS reduction was observed as early as 4
weeks after PS weaning was allowed with 33% of the patients
achieving clinical response. PS volume reduction reached a
statistically significant 40% at week 24 and the effect was
maintained with a 52% volume reduction at week 52. All patients
were clinical responders, defined as those achieving a PS volume
reduction of at least 20%. At week 52, seven out of the nine
patients (78%) achieved at least one day off PS. At week 52,
patients gained an additional 2.1 (0.7 – 3.6) days off per week
compared to a mean of 5.2 days per week on PS at baseline, which
allowed patients more independence. Apraglutide was well tolerated
with an acceptable safety profile.
“These positive data are a crucial advancement that highlight
the potential of apraglutide to be a best-in-class GLP-2 analog for
the whole spectrum of patients with SBS-IF, including those with
CIC,” said Jana Noeldeke, apraglutide life cycle leader and head of
Ironwood Pharmaceuticals’ site at Basel, Switzerland. “We welcome
these results and are continuing to progress the apraglutide
development in the SBS-IF program with a sense of urgency.”
About STARS Nutrition
STARS Nutrition is the first-ever study to prospectively
evaluate the clinical benefit of a GLP-2 analog specifically in
patients with CIC. This multicenter, open-label Phase II metabolic
balance study was designed to evaluate the effect of once-weekly
apraglutide 5-mg subcutaneous injection on intestinal absorption in
SBS-IF patients with CIC at 52 weeks. Safety and parameters
indicative of clinical efficacy, including PS volume and energy
content reduction, were assessed. The study enrolled nine adult
patients with a mean age of 46.8 years.
About Short Bowel Syndrome with Intestinal Failure
SBS-IF is a severe organ failure condition due to a reduction in
intestinal function below the minimum necessary for nutrient and
fluid absorption, leading to dependence on life-long PS to maintain
health, growth, and survival. In adults, it is typically caused by
irreparable GI damage due to inflammatory bowel disease, ischemia,
physical trauma, or surgical resection of large portions of the
small intestine. SBS-IF is an anatomically heterogeneous condition
in which the type of remnant bowel anatomy, such as CIC or stoma,
determines the therapeutic goal, medical needs, clinical response,
and the individual patient journey. Patients with the most severe
SBS-IF require PS infusions for up to 10 to 15 hours per day. SBS
is associated with frequent complications, significant morbidity
and mortality, high economic burden and an impaired quality of
life. An estimated 17,000 people are thought to suffer from SBS-IF
in the U.S. and Europe and require lifelong PS.
About Apraglutide
Apraglutide is an investigational, next-generation, long-acting
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). Apraglutide is owned by VectivBio Holding AG
(“VectivBio”), now part of Ironwood.
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.
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.
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 our ability to
develop apraglutide and the expected timing of receiving data from
the apraglutide clinical trials; the effect of apraglutide on
intestinal absorption in adult patients who have SBS-IF with CIC
and the related reduction in PS dependency; the efficacy and safety
profile of apraglutide in adult patients who have SBS-IF with CIC;
the possibility that trial outcomes could have a major impact on
clinical care and improving patient’s quality of life if confirmed
in the ongoing STARS pivotal trial; and the size of the population
that are thought to suffer from SBS-IF and SBF-IF with CIC in the
U.S. and Europe. . 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 efficacy, safety and tolerability
of linaclotide, apraglutide and other 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; 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/20231016244953/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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