– 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 –
“We are excited to advance development of IW-3718 by initiating the
Phase III trials,” said
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.
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
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.
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
Ironwood Pharmaceuticals, Inc.
Meredith Kaya, 617-374-5082
Vice President, Investor Relations and Corporate Communications