Ironwood Pharmaceuticals Inc. said IW-3718 improved heartburn symptoms better than placebo in a phase 2b study on patients with a certain digestive disorder.
The trial enrolled patients with persistent gastroesophageal reflux disease, a digestive disorder in which stomach contents frequently flow back up the esophagus. An estimated 10 million Americans have GERD.
Participants received either 1,500 milligrams of IW-3718 — plus a once a day proton pump inhibitor, or PPI — or placebo.
More than 50% of patients who received IW-3718 reported clinically meaningful reduction in heartburn severity, the company said.
The results build on earlier data that showed the drug can reduce heartburn severity and frequency of regurgitation — GERD's two most frequent symptoms.
Additionally, certain patients with erosive esophagitis, a severe inflammation and erosion of the esophagus, reported greater improvement in symptoms.
Ironwood Pharmaceuticals expects to start a phase 3 study of IW-3718 during the third quarter of 2018.
The Cambridge, Mass.-based company used proprietary technology it licensed from Depomed Inc. to develop IW-3718, which is a controlled-release formulation of colesevelam.
Colesevelam is a drug that intercepts bile acid and is marketed as Welchol in the U.S. by Daiichi Sankyo Co. Ltd., and as Cholestagel in the rest of the world by Sanofi.
