Ironwood: ‘Encouraging’ data from Phase 2b of GERD med trial

Ironwood Pharmaceuticals presented data from a double-blind, placebo-controlled, dose-ranging Phase IIb trial evaluating IW-3718 in persistent gastroesophageal reflux disease during a distinguished abstract plenary oral session at Digestive Disease Week 2018 in Washington, D.C. The data demonstrated that, compared to placebo, IW-3718 1500 mg plus a once a day proton pump inhibitor improved symptoms of heartburn severity in the overall population of GERD patients in the trial. Additionally, new data presented suggested a greater improvement in heartburn severity in the subset patient population of persistent GERD patients who also have erosive esophagitis, a severe inflammation and erosion of the esophagus. These findings build upon previously reported topline positive results from the trial, which demonstrated that IW-3718 1500 mg plus a PPI significantly reduced heartburn severity and showed reductions in frequency of regurgitation – two of the most bothersome and frequent symptoms of GERD – compared to a PPI alone. More than 50% of patients treated with IW-3718 1500 mg plus a PPI reported a clinically meaningful reduction in heartburn severity. Following these positive Phase IIb results, Ironwood expects to initiate Phase III trials during the third quarter of 2018. “These data are encouraging for physicians who continue to see their patients with GERD struggle with frequent and bothersome symptoms despite taking PPIs,” said Michael Vaezi, M.D., Ph.D. Professor of Medicine, Division of Gastroenterology, Hepatology and Nutrition, Director of the Center for Swallowing and Esophageal Disorders at Vanderbilt University Medical Center and an investigator for the study – who presented the data at DDW. “In addition to holding promise for patients with persistent GERD, these results show that IW-3718 also has potential in patients who also have erosive esophagitis despite PPI therapy – a serious condition that can cause severe damage and injury to the esophagus.”

https://bit.ly/2HkmpSd