Ironwood Pharmaceuticals announced that data from its Phase IIb clinical trial evaluating IW-3718 in adults with refractory gastroesophageal reflux disease (GERD) have been published in Gastroenterology – the official journal of the American Gastroenterological Association (AGA).
The multicenter, double-blind, placebo-controlled trial enrolled 280 patients with confirmed GERD. The patients, stratified by esophagitis status, were randomly assigned (1:1:1:1) to groups given placebo or IW-3718 (500, 1000, or 1500 mg) twice daily, with ongoing label-dose PPI. The primary end point was percent change from baseline to week 8 in weekly heartburn severity score. The trial also assessed the percent change from baseline to week 8 in weekly regurgitation frequency score.
Mean changes from baseline to week 8 in weekly heartburn severity scores were reductions of 46.0% in the placebo group, 49.0% in the 500 mg group, 55.1% in the 1000 mg group, and 58.0% in the 1500 mg IW-3718 groups). The treatment difference was 11.9% between the 1500-mg IW-3718 and placebo groups. The mean change in weekly regurgitation frequency score from baseline to week 8 in the 1500-mg IW-3718 vs placebo groups was a reduction of 17.5%. IW-3718 was well-tolerated. The most common adverse event was constipation.
IW-3718 is a novel, gastric-retentive formulation of colesevelam, a bile-acid sequestrant, developed by Ironwood using the proprietary Acuform® drug delivery formulation technology licensed from Assertio Therapeutics, Inc. IW-3718 is designed to maintain the bile-acid sequestrant in the stomach over an extended period of time where it is positioned to intercept bile before it reaches the esophagus.
About Refractory Gastroesophageal Reflux Disease (GERD)
An estimated 8 to 10 million adult Americans and more than 60 million adults globally suffer from refractory gastroesophageal reflux disease (GERD), meaning they continue to experience symptoms such as heartburn and regurgitation despite receiving treatment with a proton pump inhibitor (PPI). One of the largest and most diverse population-based surveys on gastrointestinal symptoms found that more than half (54.1 percent) of GERD patients taking PPIs still reported persistent symptoms.10 While PPIs suppress production of stomach acid, Ironwood’s clinical research demonstrates that reflux of bile from the intestine into the stomach and esophagus may play a key role in the ongoing symptoms of refractory GERD. There are no FDA-approved treatment options for these patients.