IW-3718, a novel formulation of bile acid sequestrant, significantly reduced heartburn severity in patients with uncontrolled gastroesophageal reflux disease, or GERD, according to phase 2b clinical trial results published in a press release.
Ironwood Pharmaceuticals designed IW-3718 to release in the stomach over an extended period and bind to bile that refluxes into the stomach and relieve symptoms in uncontrolled GERD. In this study, IW-3718 achieved a clinically significant reduction in heartburn severity in more than 50% of patients treated with twice daily, oral IW-3718 1,500 mg plus a proton pump inhibitor (PPI). After their end of phase 2 meetings with the FDA, Ironwood Pharmaceuticals plans to advance IW-3718 1,500 mg into phase 3 development in 2018.
“The data from this trial are encouraging, as they provide strong evidence that bile plays a key role in uncontrolled GERD and that IW-3718 may bring a much-needed new approach to treating these patients,” Michael Vaezi, MD, PhD, professor of medicine in the division of gastroenterology and hepatology, director of the Center for Swallowing and Esophageal Disorders at Vanderbilt University Medical Center and an investigator for the study, said in the release.
The researchers determined the percent change from baseline to week 8 in weekly heartburn severity in patients receiving IW-3718. Analysis showed that patients treated with IW-3718 1,500 mg plus a PPI experienced a mean decrease of 58% from baseline in heartburn severity vs. 46% in patients treated with a PPI alone (P = .04). Researchers also observed that 52.9% of patients receiving IW-3718 1,500 mg plus a PPI experienced at least a 45% reduction from baseline in heartburn severity for at least 4 of 8 weeks vs. 37.1% of patients receiving a PPI alone. Patients taking IW-3718 1,500 mg plus a PPI showed a mean decrease of 55.4% from baseline in regurgitation frequency vs. 37.9% in patients taking a PPI alone (P = .01).
There were no treatment-related serious adverse events reported in patients treated with IW-3718 1,500 mg.
“The results from this trial, demonstrating encouraging improvements in heartburn severity and regurgitation, appear to validate our approach of targeting bile acid reflux in patients with uncontrolled GERD in addition to suppressing acid with PPIs,” Mark Currie, PhD, senior vice president, chief scientific officer and president of research and development at Ironwood, said. “These data were consistent and robust across key endpoints, and reinforce our belief that IW-3718 may lead to meaningful symptom relief for patients with uncontrolled GERD.”
Currie is an employee of Ironwood Pharmaceuticals. Healio Gastroenterology was unable to confirm any relevant financial disclosures for Vaezi at the time of publication.