An experimental drug known as IW-3718 (Ironwood Pharmaceuticals) is showing success in clincial studies. The product is meant to treat refractive gastroesphageal reflux disease (GERD). That is defined as continued heartburn, regurgitation, or both, despite treament with proton pump inhibitors. Reporting at the American College of Gastroenterology Scientific Meeting in Honolulu Oct. 16 to Oct. 21, Michael Vaezi, MD, PhD, MSc, of Vanderbilt University Medical Center and colleagues described the drug as a novel gastric-retentive formulation of a bile sequestrant designed to bind to bile acids in the refluxate.
In a phase 2a trial 93 patients were randomized into treatment and placebo groups.
The percentage of patients free of regurgiation at week four of the trial was significantly higher in the group getting IW-3718.
"The degree of relief for overall GERD symptoms and percent of patients free of heartburn were numerically greater for IW-3718 versus placebo," they wrote in an abstract presented at the conference.
There were adverse events in 48% of the patients, mostly reports of constipation, butnearly a third of the placebo patients also reported that as a side effect (32% of patients.)
The team said the drug was well-tolerated and that the study supports the hypothesis that bile acid sequestration can reduce refractory GERD symptoms.
About 8 million people in the US suffer from refractory GERD, according to a news release on IW-3718 issued earlier this year by Ironwood. The company is based in Cambridge, MA.