Ironwood Pharmaceuticals Reports Positive Top-line Results from IW-3718 Phase IIb Trial in Uncontrolled Gastroesophageal Reflux Disease
– IW-3718 1500 mg demonstrated a significant reduction in heartburn severity in patients with uncontrolled GERD –
– Greater than 50% of patients treated with IW-3718 1500 mg achieved a clinically meaningful reduction in heartburn severity –
– IW-3718 1500 mg also showed reductions in regurgitation frequency –
– Ironwood expects to advance IW-3718 into Phase III –
– Conference call scheduled today at
Uncontrolled GERD is a chronic condition affecting an estimated 10 million Americans who continue to suffer from symptoms such as heartburn and regurgitation despite receiving treatment with PPIs – the current standard of care – to suppress acid produced in the stomach. Ironwood’s clinical research has demonstrated that reflux of bile from the intestine into the stomach and esophagus plays a key role in the ongoing symptoms of uncontrolled GERD. IW-3718 is a novel formulation of a bile acid sequestrant designed to release in the stomach over an extended period of time, bind to bile that refluxes into the stomach, and potentially provide symptomatic relief in uncontrolled GERD.
“Millions of patients with GERD globally are significantly impacted by
frequent and bothersome heartburn and regurgitation symptoms despite
diligently taking their PPIs. They are seeking relief, asking for new
treatment options and we really have nothing to offer them,” said
Data from the Phase IIb trial showed a dose response across the primary and key secondary endpoints, with the most pronounced response observed at the highest dose of IW-3718 studied (1500 mg). Top-line data were as follows:
There were no treatment-related serious adverse events reported with IW-3718 1500 mg. The most common adverse event reported overall was constipation, which was reported in 7.4% of patients on IW-3718 1500 mg plus a PPI (n=5) compared to 7.1% of patients on a PPI alone (n=5). 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.
“The results from this trial, demonstrating encouraging improvements in
heartburn severity and regurgitation, appear to validate our approach of
targeting bile acid reflux in patients with uncontrolled GERD in
addition to suppressing acid with PPIs,” said
Ironwood intends to present additional data from the Phase IIb clinical trial at an upcoming scientific meeting and/or via peer-reviewed publications.
IW-3718 is wholly-owned by Ironwood. Ironwood has existing patents and pending patent applications for IW-3718 that are expected to provide patent coverage into the mid-2030s.
Conference Call Information
Ironwood will host a conference call and webcast at
Phase IIb Trial Design
The randomized, double-blind, placebo-controlled Phase IIb clinical trial enrolled 282 adult patients with GERD (including 276 adult patients with baseline regurgitation), confirmed by endoscopy, who were taking a PPI and continuing to experience GERD symptoms, including heartburn and regurgitation, at least four days per week during the previous eight weeks. The trial included a two-week pretreatment period, during which baseline symptoms were assessed via an electronic diary. Patients were then randomly assigned to receive either placebo or one of three doses of IW-3718 (500 mg, 1,000 mg or 1,500 mg) twice daily for eight weeks, in addition to their daily PPI therapy. The primary efficacy endpoint was percent change in weekly heartburn severity from baseline to week 8. Additionally, a heartburn responder endpoint was defined based on a clinically meaningful degree of improvement derived for the uncontrolled GERD population from patient reported outcome measures collected in the study. No adjustments were made for multiplicity; p-values were reported as nominal.
IW-3718 is a novel, gastric retentive formulation of a bile acid
sequestrant, developed by Ironwood using the proprietary Acuform® drug
delivery formulation technology licensed from
About Uncontrolled Gastroesophageal Reflux Disease (GERD)
An estimated 10 million adult Americans and more than 60 million adult
patients globally suffer from uncontrolled gastroesophageal reflux
disease (GERD), meaning they continue to experience symptoms such as
heartburn and regurgitation despite receiving treatment with a proton
pump inhibitor (PPI). 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 uncontrolled GERD.
ACUFORM® is a registered trademark of
This press release contains forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, including statements about the topline assessment of the data from the Phase IIb clinical trial of IW-3718; the development, regulatory and commercialization plans for IW-3718, and the timing thereof, including further investigation and advancement of IW-3718, engaging with the FDA, advancing IW-3718 into Phase III development and commercializing IW-3718 within and outside the U.S.; the design of the Phase IIb trial and its impact on the results thereof, as well as the results and their validation of our approach to targeting bile acid reflux in patients with uncontrolled GERD and expectations relating to replication in Phase III; the timing of presentation of additional IW-3718 Phase IIb data; the design, potential indications for, and possible benefits of IW-3718 and its potential as a treatment for patients with uncontrolled GERD; the potential for patient adherence to IW-3718; the level of competition in the uncontrolled GERD space; physicians’ willingness to adopt and the potential for broad payer access and reimbursement; prevalence and unmet need; market size, growth and opportunity, including peak sales and potential demand for IW-3718 in the U.S.; and the strength of the intellectual property protection for IW-3718. 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; the risk that future clinical studies need to be discontinued for any reason, including safety, tolerability, enrollment, manufacturing or economic reasons; 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; the risk that the therapeutic opportunities for IW-3718 are not as we expect; decisions by regulatory authorities; those risks related to competition and future business decisions made by us and our competitors or potential competitors; the risk that we may never get sufficient patent protection for IW-3718 or that we are not able to successfully protect such patents; developments in the intellectual property landscape; 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, 2017, 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.
Ironwood Pharmaceuticals, Inc.
|"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding Ironwood Pharmaceuticals's business which are not historical facts are "forward-looking statements" that involve risks and uncertainties. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see "Risk Factors" in the Company's Annual Report or Form 10-K for the most recently ended fiscal year.|
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