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Ironwood GERD med meets primary endpoint in Phase 2b trial

July 20, 2017

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a commercial biotechnology company, announced positive top-line data from a Phase IIb clinical trial evaluating IW-3718 in adult patients with uncontrolled gastroesophageal reflux disease (GERD). The trial met its primary endpoint, indicating that twice-daily, oral dosing of IW-3718 1500 mg plus a proton pump inhibitor (PPI) significantly reduced heartburn severity in patients with uncontrolled GERD compared to patients treated with a PPI alone. Further, more than half of patients treated with IW-3718 1500 mg plus a PPI achieved a clinically meaningful reduction in heartburn severity. IW-3718 1500 mg was well tolerated in the trial. Ironwood plans to have end of Phase II meetings with the U.S. Food and Drug Administration (FDA), after which the company expects to advance IW-3718 1500 mg into Phase III development in the second half of 2018.

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 Michael Vaezi, M.D., Ph.D., professor of medicine, division of gastroenterology and hepatology, director of the Center for Swallowing and Esophageal Disorders at Vanderbilt University Medical Center and an investigator for the study. “The data from this trial are encouraging, as they provide strong evidence that bile plays a key role in uncontrolled GERD and that IW-3718 may bring a much-needed new approach to treating these patients.”

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:

  • Percent Change from Baseline to Week 8 in Weekly Heartburn Severity (primary endpoint): patients treated with IW-3718 1500 mg plus a PPI showed a mean decrease of 58.0% from baseline in heartburn severity compared to 46.0% in patients treated with a PPI alone (p = 0.04).
  • Clinically Meaningful Degree of Improvement in Weekly Heartburn Severity: a 45% reduction in weekly heartburn severity was determined to be clinically meaningful for patients in this study based on patient-reported outcome measures.
  • Heartburn Responder: a heartburn responder was defined as a patient who experienced at least a 45% reduction from baseline in heartburn severity for at least four out of eight weeks, including at least one of the last two weeks. 52.9% of patients treated with IW-3718 1500 mg plus a PPI were heartburn responders, compared to 37.1% of patients treated with a PPI alone.
  • Percent Change from Baseline to Week 8 in Weekly Regurgitation Frequency: patients treated with IW-3718 1500 mg plus a PPI showed a mean decrease of 55.4% from baseline in regurgitation frequency compared to 37.9% in patients treated with a PPI alone (among patients with baseline regurgitation; p = 0.01).

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 Mark Currie, Ph.D., senior vice president, chief scientific officer, and president of research and development at Ironwood. “These data were consistent and robust across key endpoints, and reinforce our belief that IW-3718 may lead to meaningful symptom relief for patients with uncontrolled GERD.”

Ironwood intends to present additional data from the Phase IIb clinical trial at an upcoming scientific meeting and/or via peer-reviewed publications.

http://bit.ly/2ubUor7

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