Investigational Drug May Reduce Symptoms in Refractory GERD

February 27, 2020

A new study tested the investigational drug in combination with proton pump inhibitors for patients with gastroesophageal reflux disease.

Researchers have identified a potential new drug that could reduce heartburn severity in patients with treatment-resistant gastroesophageal reflux disease (GERD) when combined with a proton pump inhibitor (PPI), according to a study published in Gastroenterology.

Although PPIs are commonly used to treat GERD, approximately 30% of patients still experience symptoms despite taking their PPIs.

The safety and efficacy of IW-3718, an investigational drug that binds bile acid in the stomach, was evaluated as an adjunct to PPI therapy in a clinical study.

The study included 280 patients with confirmed GERD who received either placebo or 500, 1000, or 1500 mg of IW-3718 twice daily, with ongoing label-dose PP, from March 2016 through April 2017. Heartburn severity and regurgitation frequency was assessed.

According to the results, the main changes from baseline to week 8 in weekly heartburns severity scores showed reduction of 46% in the placebo group, 49% in the 500-mg group, 55.1% in the 1000-mg group, and 58% in the 1500-mg group (dose-response P=.02). The treatment difference was 11.9% between the 1500-mg IW-3718 group and the placebo groups (P=.04, analysis of covariance).

For weekly regurgitation frequency in the 1500-mg group versus the placebo group, there was a 17.5% reduction (95% CI, reductions of 31.4% to 3.6%).

IW-3718 was also generally well tolerated, with the most common adverse event (AE) being constipation. There were no drug-related serious AEs.

“These data provide strong evidence that bile acid plays a key role in refractory GERD and that IW-3718 may have the potential to make a meaningful difference for patients,” Michael Vaezi, MD, PhD, MSc, director of the Center for Swallowing and Esophageal Disorders at Vanderbilt University Medical Center, said in a press release about the study.

References:

1. Vaezi MF, Fass R, Vakil N, et al. IW-3718 reduces heartburn severity in patients with refractory gastroesophageal reflux disease in a randomized trial. Gastroenterology. 2020. DOI: https://doi.org/10.1053/j.gastro.2020.02.031

2. Potential new heartburn drug studied at VUMC [news release]. VUMC’s website. https://news.vumc.org/2020/02/26/potential-new-heartburn-drug-studied-at-vumc/. Accessed February 26, 2020.