– Apraglutide met the primary endpoint of
relative change from baseline in actual weekly parenteral support
(PS) volume at week 24, driven by both stoma and
colon-in-continuity populations –
– Apraglutide also showed a clinically
meaningful improvement at week 24, with patients achieving at least
one day off PS per week –
– Apraglutide was generally well-tolerated, and
the safety profile was consistent with previously-reported studies
of apraglutide in this patient population –
– Ironwood to submit new drug application and
other regulatory filings for apraglutide as a once-weekly GLP-2
analog for use in adult patients with SBS who are dependent on PS
–
– Ironwood to host conference call and webcast
today at 8:00 a.m. ET –
Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused
healthcare company, today announced positive topline results from
its pivotal Phase III STARS trial, which evaluated the efficacy and
safety of once-weekly subcutaneous apraglutide in reducing
parenteral support (PS) dependency in adult patients with short
bowel syndrome with intestinal failure (SBS-IF). SBS-IF, a rare and
severe organ failure condition in which patients are dependent on
PS, affects an estimated 18,000 adult patients in the U.S., Europe,
and Japan. Based on these results, Ironwood plans to submit a new
drug application (NDA) and other regulatory filings for apraglutide
for use in adult patients with SBS who are dependent on PS.
The global, multicenter, double-blind, randomized,
placebo-controlled trial evaluated the efficacy and safety of
weekly subcutaneous injections of apraglutide in adult patients
with SBS-IF. The trial met its primary endpoint of relative change
from baseline in actual weekly PS volume at week 24, comparing
apraglutide versus placebo (-25.5% vs. -12.5%; p=0.001).
“Reducing dependency on parenteral support and easing treatment
burden are important goals for every patient with SBS-IF,” said
Kishore R Iyer, MBBS, FRCS (Eng), FACS, Director of Adult and
Pediatric Intestine Rehabilitation & Transplantation at The
Mount Sinai Hospital in New York, Coordinating Principal
Investigator of the trial, paid scientific advisor to Ironwood and
chair of the scientific steering committee for the STARS Trial.
“The STARS topline results are significant as this is the first
successful Phase III placebo-controlled study in SBS-IF patients
with a GLP-2 analog with once-weekly dosing.”
In addition, there were four key secondary endpoints evaluated
in statistical hierarchy. Apraglutide demonstrated statistical
significance for the first two key secondary endpoints, with more
patients in the combined population achieving at least one day/week
off PS relative to baseline at week 24 versus placebo (43.0% vs.
27.5%; p=0.040) and more patients treated with apraglutide versus
placebo demonstrating improvement in relative change from baseline
in actual weekly PS volume at week 24 in the stoma population
(-25.6% vs. -7.8%; p<0.001). The third and fourth key secondary
endpoints were specific to colon-in-continuity patients in
assessing at least one day/week off PS versus baseline and reaching
enteral autonomy at week 48, both of which were not achieved.
Apraglutide was numerically favorable but not statistically
significant relative to placebo for improving days off PS (51.8%
versus 44.4%) and reaching enteral autonomy in seven out of 56
(12.5%) patients versus two out of 27 (7.4%) patients on
placebo.
Apraglutide was generally well-tolerated. Topline safety results
were generally consistent with the safety profile demonstrated in
apraglutide studies to date.
“Patients with SBS-IF bear the dual burden of a devastating
condition and a complex treatment regimen that includes hours of
parenteral support, which significantly impacts their quality of
life and carries a risk of severe complications such as infection,”
said Michael Shetzline, M.D., Ph.D., chief medical officer, senior
vice president and head of research and drug development at
Ironwood Pharmaceuticals. “We believe these results demonstrate the
potential for apraglutide to improve the standard of care for all
adult patients with SBS dependent on parenteral support as the only
GLP-2 with once-weekly administration, if approved. We are thankful
to the patients and clinical investigators involved in the largest
study of a GLP-2 analog in SBS-IF and will work with regulators on
next steps with the goal of making apraglutide available to those
living with this severe condition.”
Ironwood looks forward to presenting additional data from the
STARS study at upcoming medical conferences later this year.
About STARS
The STARS (STudy of ApRaglutide in SBS) pivotal Phase III trial
represents the largest Phase III trial in SBS-IF to date.
This global, multicenter, double-blind, randomized,
placebo-controlled trial evaluated the efficacy and safety of
weekly subcutaneous injections of apraglutide in adult patients
with SBS-IF. STARS enrolled 164 patients and dosed 163 stratified
approximately 50/50 (stoma vs. colon-in continuity), then evaluated
them over 24 weeks (stoma and colon-in-continuity populations) and
48 weeks (colon-in-continuity population only). Patients were
randomized 2:1 to either once weekly apraglutide or placebo. The
primary endpoint was relative change from baseline in actual weekly
PS volume at week 24. Key secondary endpoints included patients who
achieved a reduction from baseline of at least 1 day/week of PS at
week 24 (all patients); relative change from baseline in actual
weekly PS volume at week 24 (stoma population); patients who
achieved a reduction from baseline of at least 1 day/week of PS at
week 48 (colon-in-continuity population); and patients reaching
enteral autonomy at week 48 (colon-in-continuity population).
The study was conducted in 18 countries with 68 active
sites.
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, also referred to as SBS with
intestinal failure (SBS-IF), often experience significant quality
of life impact and are at risk of severe complications such as
infection. 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.
Conference Call
Ironwood will host a conference call and webcast today,
Thursday, February 29, 2024 at 8:00 a.m. Eastern Time to discuss
the topline results. Individuals interested in participating in the
call should dial (800) 715-9871 (U.S. and Canada) or (646) 307-1963
(international) using conference ID number and event passcode
2684639. To access the webcast, please visit the Investors section
of Ironwood’s website at www.ironwoodpharma.com. The call will be available
for replay via telephone starting at approximately 11:30 a.m.
Eastern Time on February 29, 2024, running through 11:59 p.m.
Eastern Time on March 14, 2024. To listen to the replay, dial (800)
770-2030 (U.S. and Canada) or (609) 800-9909 (international) using
conference ID number 2684639. The archived webcast will be
available on Ironwood’s website for 1 year beginning approximately
one hour after the call has completed.
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
(SBS) 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) dependent on PS 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 efficacy and safety of apraglutide; Ironwood’s
plan to submit an NDA and other regulatory filings for apraglutide;
the estimated adult population who suffer from SBS-IF in the U.S.,
Europe and Japan; the belief that the clinical trial results
demonstrate the potential for apraglutide to improve the standard
of care for all adult patients with SBS dependent on PS and the
potential availability of apraglutide. 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/20240229041690/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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