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Ironwood Pharmaceuticals Announces Publication of Positive IW-3718 Phase IIb Data in Gastroenterology
– Data showed improvement in both heartburn and regurgitation symptoms and further demonstrated the role of bile acid in refractory gastroesophageal reflux
About this update from Ironwood Pharmaceuticals, Inc.
[{"type":"text","content":"\n– Data showed improvement in both heartburn and regurgitation symptoms and further demonstrated the role of bile acid in refractory gastroesophageal reflux disease (GERD) –\n\n\n– IW-3718 is currently in two Phase III trials; top line data targeted for second half of 2020 –\n\n BOSTON--(BUSINESS WIRE)--\n\nIronwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a GI-focused healthcare company, today announced that Gastroenterology - the official journal of the American Gastroenterological Association (AGA) - has published data from its Phase IIb clinical trial evaluating IW-3718 in adults with refractory gastroesophageal reflux disease (GERD). The data demonstrated that IW-3718 1500 mg given twice daily (BID) plus a proton pump inhibitor (PPI) significantly reduced heartburn severity and reduced the frequency of regurgitation – two of the most bothersome and frequently reported symptoms of GERD1 – compared to a PPI alone. Additionally, more than 50 percent of patients treated with IW-3718 1500 mg BID plus a PPI reported a clinically meaningful reduction in heartburn severity. IW-3718 was well-tolerated in the trial; the most common adverse event reported overall was constipation. Data from this study were previously presented at Digestive Disease Week® (DDW) in Washington, D.C., June 2018.\n\n\nThe publication can be accessed at the following link: https://www.gastrojournal.org/article/S0016-5085(20)30242-0/fulltext\n\n\nRefractory GERD affects an estimated 8 to 10 million Americans2,3,4,5 who continue to suffer from heartburn and regurgitation despite receiving treatment with PPIs - the current standard of care. Research suggests that PPIs block gastric acid from refluxing into the esophagus, but do not suppress reflux of bile acids, which have been implicated as contributors to refractory GERD symptoms. IW-3718 is a novel gastric retentive formulation of a bile acid sequestrant designed to release in the stomach over an extended period where it is positioned to bind to bile before it reaches the esophagus.\n\n\n“As a physician, it is very challenging to have no approved treatments to offer patients for whom standard treatments don’t work, but the reality is many of our patients continue to struggle with frequent heartburn and regurgitation despite taking their PPIs,” said lead author Michael Vaezi, M.D., Ph.D. Professor of Medicine, ...