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Ironwood Announces Updates Designed to Strengthen IW-3718 Phase III Program for Refractory Gastroesophageal Reflux Disease (GERD)
– Changed primary endpoint to continuous from current responder endpoint, in-line with recent FDA guidance and very similar to IW-3718 Phase IIb trial – –
About this update from Ironwood Pharmaceuticals, Inc.
[{"type":"text","content":"\n– Changed primary endpoint to continuous from current responder endpoint, in-line with recent FDA guidance and very similar to IW-3718 Phase IIb trial –\n\n\n– Conducting early assessment of IW-3718-302, one of two identical Phase III trials; expect to report outcome of assessment in 4Q 2020 –\n\n\n– Ironwood to host conference call today at 8:30 a.m. Eastern Time –\n\n BOSTON--(BUSINESS WIRE)--\n\nIronwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a leading GI-focused healthcare company, today announced that it has reached alignment with the U.S. Food and Drug Administration (FDA) on certain updates to its Phase III clinical program evaluating IW-3718 in adults with refractory gastroesophageal reflux disease (GERD). The updates are as follows:\n\n\n\nThe primary endpoint for the two identical trials – IW-3718-301 and IW-3718-302 – has been changed from the previous responder endpoint to a continuous endpoint.\n\n\nIronwood plans to stop enrollment of study subjects into IW-3718-302 and to conduct a blinded early assessment of efficacy in that trial; the company expects to report the outcome of this assessment in the fourth quarter of 2020.\n\n\n\n“Following discussions with the FDA, we are making important updates that we believe will strengthen the overall Phase III program despite the enrollment delays we have seen due to the COVID-19 pandemic,” said Mike Shetzline, M.D., Ph.D., chief medical officer, senior vice president and head of drug development at Ironwood. “These updates are designed to maintain the scientific integrity of the trials without adding risk to the development program.”\n\n\n“We believe IW-3718 represents an exciting opportunity, if approved, to bring a medicine to the estimated 8 to 10 million adult Americans with refractory GERD in need of treatment options for their highly bothersome symptoms of heartburn and regurgitation despite being on PPI therapy,” said Tom McCourt, president of Ironwood. “We are working with the FDA to advance IW-3718 quickly and safely, given the high unmet need in this patient population.”\n\n\nIronwood is also in discussions with the FDA regarding its request for long-term safety data for IW-3718 in refractory GERD patients. Ironwood has provided a detailed overview of the existing long-term safety data for colesevelam and is working closely with the FDA to determine whether any ...