– 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 –
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun. 21, 2018--
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180621006206/en/
Source: Ironwood Pharmaceuticals, Inc.
Ironwood Pharmaceuticals, Inc.
Meredith Kaya, 617-374-5082
Vice
President, Investor Relations and Corporate Communications
mkaya@ironwoodpharma.com