Ironwood Pharmaceuticals Initiates Pivotal Phase III Program for IW-3718 in Persistent Gastroesophageal Reflux Disease
June 21 2018 - 4:05PM
Business Wire
– Program Designed to Support U.S. Regulatory
Filing of IW-3718 as Potential Treatment for Patients Who Continue
to Suffer From GERD Despite Receiving Standard of Care –
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a commercial
biotech company, today announced the initiation of two Phase III
clinical trials evaluating the safety and efficacy of IW-3718 in
patients with persistent gastroesophageal reflux disease (GERD).
Persistent GERD affects an estimated 10 million Americans who
continue to suffer from heartburn and regurgitation despite
receiving treatment with proton pump inhibitors (PPIs), the current
standard of care.
“We are excited to advance development of IW-3718 by initiating
the Phase III trials,” said Christopher Wright, M.D., Ph.D., senior
vice president, global development and chief development officer at
Ironwood. “Pre-clinical and clinical evidence suggest that IW-3718
may offer a treatment option for the millions of patients with GERD
who continue to experience frequent and bothersome symptoms such as
heartburn and regurgitation despite taking PPIs. Our teams have
done excellent work to rapidly initiate these trials. We are
hopeful that these studies will generate data in support of a
potential approval as quickly as possible.”
The Phase III program comprises two identical randomized,
double-blind, placebo-controlled, multicenter Phase III trials that
target enrolling approximately 1,320 patients total (660 in each
trial) with persistent GERD who demonstrate evidence of
pathological acid reflux. Eligible patients will continue to take
PPIs and be randomized to placebo or IW-3718 1500 mg twice a day
for eight weeks.
The primary endpoint is overall heartburn responder, defined as
a patient who experiences at least a 45% reduction from baseline in
heartburn severity (an improvement determined to be clinically
meaningful based on patient-reported outcomes in the Phase IIb
trial) for at least four out of eight weeks, including at least one
of the last two weeks. Secondary endpoints include change in weekly
heartburn severity, change in weekly regurgitation frequency and
the proportion of heartburn-free days.
Data from the 280 patient IW-3718 Phase IIb trial in patients
with persistent GERD showed that 1500 mg twice daily as an adjunct
therapy to PPIs significantly reduced heartburn severity and showed
reductions in frequency of regurgitation – two of the most
bothersome and frequent symptoms of GERD – compared to a PPI alone.
The most common adverse event reported overall in the Phase IIb
trial was constipation (IW-3718 + PPI = 7.4% vs. PPI alone = 7.1%);
all constipation adverse events reported were mild or moderate in
severity. Discontinuation rates due to adverse events were less
than 5% and similar across treatment groups.
About IW-3718
IW-3718 is a novel, gastric retentive formulation of
colesevelam, a bile acid sequestrant, developed by Ironwood using
the proprietary Acuform® drug delivery formulation technology
licensed from Depomed, Inc. IW-3718 is designed to deliver the bile
acid sequestrant to the stomach over an extended period where it is
positioned to intercept bile before it reaches the esophagus. Data
from non-clinical and clinical studies collectively support the
extended release and gastric-retentive profile of IW-3718. Ironwood
has existing patents and pending patent applications for IW-3718
that are expected to provide patent coverage into the
mid-2030s.
About Persistent Gastroesophageal Reflux Disease
(GERD)
An estimated 10 million adult Americans and more than 60 million
adult patients globally suffer from persistent gastroesophageal
reflux disease (GERD), meaning they continue to experience symptoms
such as heartburn and regurgitation despite receiving treatment
with proton pump inhibitors (PPIs). While PPIs suppress production
of stomach acid, Ironwood’s clinical research demonstrates that
reflux of bile from the intestine into the stomach and esophagus
plays a key role in the ongoing symptoms of persistent GERD.
FDA-approved treatment options for these patients are limited.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (NASDAQ: IRWD) is a commercial
biotechnology company focused on creating medicines that make a
difference for patients, building value for our fellow
shareholders, and empowering our passionate team. We are
commercializing two innovative primary care products: linaclotide,
the U.S. branded prescription market leader for adults with
irritable bowel syndrome with constipation (IBS-C) or chronic
idiopathic constipation (CIC), and lesinurad, which is approved to
be taken with a xanthine oxidase inhibitor (XOI), or as a
fixed-dose combination with allopurinol, for the treatment of
hyperuricemia associated with gout. We are also advancing a
pipeline of innovative product candidates in areas of significant
unmet need, including persistent gastroesophageal reflux disease,
diabetic nephropathy, heart failure with preserved ejection
fraction, achalasia and sickle cell disease. Ironwood was founded
in 1998 and is headquartered in Cambridge, Mass. For more
information, please visit ironwoodpharma.com/ or
twitter.com/ironwoodpharma; information that may be important to
investors will be routinely posted in both these locations.
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 prevalence
of persistent GERD, program design, the generation of data in
support of a potential approval, and the expected period of patent
coverage for IW-3718. Applicable risks and uncertainties include
those related to preclinical and clinical development,
manufacturing and formulation development; the risk that findings
from our completed nonclinical and clinical studies may not be
replicated in later studies; efficacy, safety and tolerability of
IW-3718; decisions by regulatory and judicial authorities; the risk
that we are unable to successfully commercialize IW-3718, if
approved; the risk that we may never get sufficient patent
protection for IW-3718 or that we are not able to successfully
protect such patents; the outcomes in legal proceedings to protect
or enforce the patents relating to our products and product
candidates; developments in the intellectual property landscape;
challenges from and rights of competitors or potential competitors;
the risk that our planned investments do not have the anticipated
effect on our company revenues, products or product candidates; the
risk that we are unable to manage our operating expenses or cash
use for operations, or are unable to commercialize our products,
within the guided ranges or otherwise as expected; and the risks
listed under the heading "Risk Factors" and elsewhere in Ironwood's
Quarterly Report on Form 10-Q for the quarter ended March 31, 2018,
and in our subsequent SEC filings. These forward-looking statements
(except as otherwise noted) speak only as of the date of this press
release, and Ironwood undertakes no obligation to update these
forward-looking statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20180621006206/en/
Ironwood Pharmaceuticals, Inc.Meredith Kaya, 617-374-5082Vice
President, Investor Relations and Corporate
Communicationsmkaya@ironwoodpharma.com
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