Ironwood IW-3718 Phase IIb trial meets primary endpoint
Ironwood Pharmaceuticals (IRWD) announced positive top-line data from a Phase IIb clinical trial evaluating IW-3718 in adult patients with uncontrolled #gastroesophageal #reflux disease.
The trial met its primary endpoint, indicating that twice-daily, oral dosing of IW-3718 1500 mg plus a proton pump inhibitor 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, after which the company expects to advance IW-3718 1500 mg into Phase III development in 2H18.
#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.
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. Top-line data were as follows: Percent Change from Baseline to Week 8 in Weekly Heartburn Severity: patients treated with IW-3718 1500 mg plus a PPI showed a mean decrease of 58% from baseline in heartburn severity compared to 46% in patients treated with a PPI alone.
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. 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 compared to 7.1% of patients on a PPI alone. 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.
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