– Apraglutide nutritional data from STARS
Nutrition Phase 2 study in adult patients who have short bowel
syndrome with intestinal failure and colon-in-continuity will be
highlighted in an oral presentation –
– Additional data on apraglutide from
previously completed Phase 1 and Phase 2 studies will also be
highlighted in poster presentations –
Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a
GI-focused healthcare company, announced today that the company
will present findings from four studies evaluating apraglutide in
adults with short bowel syndrome with intestinal failure (SBS-IF),
a condition in which they are dependent on parenteral support,
during the American Society for Parenteral and Enteral Nutrition
(ASPEN) 2024 Nutrition Science & Practice Conference. ASPEN is
being held from March 2-5, 2024, in Tampa, Florida.
SBS is a serious and chronic condition where there is diminished
absorptive capacity for fluids and/or nutrients, typically
resulting from extensive intestinal resection. Adult patients with
SBS who are dependent on parenteral support (PS) to meet their
nutritional and hydration needs, also referred to as SBS-IF, have
significant quality of life impact and risk of severe complications
such as infection. In these patients with SBS who are dependent on
PS, the type of remnant bowel anatomy, such as colon-in-continuity
or the presence of a jejunostomy or ileostomy, plays a critical
role in how they respond to treatment.
The data being presented on apraglutide will include an oral
presentation of fluid and energy absorption results at 4 weeks in
SBS-IF with colon-in-continuity from the STARS Nutrition clinical
trial, and poster presentations on apraglutide’s effect on
reduction in PS needs and its safety profile in patients with
SBS-IF with colon-in-continuity at one year, an epidemiological
study of SBS-IF using real-world data, and an analysis of the
pharmacokinetics of apraglutide in people with normal and impaired
hepatic function.
“We are excited to share these findings on apraglutide with the
international community of nutrition experts at ASPEN, a meeting
which is singularly focused on critical nutrition support,” said
Michael Shetzline, M.D., Ph.D., chief medical officer, senior vice
president, and head of research and drug development at Ironwood
Pharmaceuticals. “These findings continue to deepen our
understanding of GLP-2 and the potential of apraglutide to help
adult patients with SBS who are dependent on PS, including those
with colon-in-continuity. Our hope is that if approved, apraglutide
will have a positive impact on these patients.”
An estimated 18,000 adult patients in the U.S., Europe, and
Japan suffer from SBS-IF, a rare and severe organ failure condition
resulting from extensive intestinal resection, in which patients
are dependent on PS to meet their nutritional and fluid
requirements.
An overview of the presentations is below. Presentation details
(abstracts, when available, can be accessed on the ASPEN 2024
meeting website at https://www.nutritioncare.org/abstracts/):
- The Novel Long-Acting Glp-2 Analog Apraglutide Improves Wet
Weight Absorption in Patients with Short Bowel Syndrome with
Intestinal Failure and Colon-In-Continuity
- Oral presentation: March 3, 2:00 – 3:30 p.m. ET
- The Long-Acting GLP-2 Analog Apraglutide Reduces Parenteral
Support Needs in Patients with Short Bowel Syndrome With Intestinal
Failure and Colon in Continuity: 1-Year Results of a Multicenter,
Open-Label, Phase 2 Trial
- Poster presentation: March 3 and 4, 12:45 – 1:45 p.m. ET
- Epidemiology of Patients with Short Bowel Syndrome with
Intestinal Failure (SBS-IF) in the US – Findings Using Real-World
Data
- Poster presentation: March 3 and 4, 12:45 – 1:45 p.m. ET
- Pharmacokinetics and Safety of Single-Dose Apraglutide in
Individuals with Normal and Impaired Hepatic Function: A Phase 1,
Open-Label Trial
- Poster presentation: March 3 and 4, 12:45 – 1:45 p.m. ET
Ironwood is also sponsoring an Innovation Theater presentation
entitled “Oral Nutrition in the Era of GLP-2: An Essential Factor
in Maximizing Intestinal Adaptation for Patients With SBS-IF” on
Sunday, March 3, from 12:45 to 1:30 p.m. ET. The presentation is
chaired by Dr. Dejan Micic from the University of Chicago and will
be joined by the faculty for an in-depth discussion on the
importance of oral nutrition for patients with SBS-IF in the era of
GLP-2 treatment.
About Short Bowel Syndrome (SBS)
SBS is a serious and chronic condition where there is diminished
absorptive capacity for fluids and/or nutrients, sometimes
requiring dependence on parenteral support to maintain health.
Short bowel syndrome typically occurs because of extensive
intestinal resection, and patients with SBS who are chronically
dependent on parenteral support often experience significant
quality of life impact and are at risk of severe complications such
as infection. Patients with SBS with intestinal failure (SBS-IF)
require PS to meet their nutritional and hydration needs, and the
type of remnant bowel anatomy, such as colon-in-continuity or the
presence of a jejunostomy or ileostomy, plays a critical role in
how they respond to treatment.
An estimated 18,000 adult patients suffer from SBS-IF in the
U.S., Europe and Japan, and have chronic dependence on PS, which
significantly impacts quality of life and carries the risk of
severe complications such as infection. Those with the most severe
SBS-IF require PS infusions for up to 10 to 15 hours per day.
SBS-IF is associated with frequent complications, significant
morbidity and mortality, high economic burden and an impaired
quality of life. SBS is an anatomically heterogenous condition in
which the type of remnant bowel anatomy - such as presence of
absence of colon-in-continuity - influences the pathophysiology and
determines the degree of PS dependence, therapeutic goal, medical
needs and clinical response to treatment.
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).
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
therapeutic potential of apraglutide, if approved, and the
estimated population suffer from SBS-IF in the U.S., Europe and
Japan. 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 preclinical and clinical development, manufacturing and
formulation development of apraglutide; the risk that clinical
programs and studies, including for apraglutide, 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 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;
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/20240223104623/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
Ironwood Pharmaceuticals (NASDAQ:IRWD)
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Ironwood Pharmaceuticals (NASDAQ:IRWD)
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