Study Finds Investigational GERD Therapy Reduces Reflux Symptoms

Researchers have reported the efficacy of a novel bile acid sequestrant as an adjunct to treatment of gastroesophageal reflux disease (GERD) with proton pump inhibitors (PPIs), in reducing reflux symptoms.

Ronnie Fass, MD, director of the Division of Gastroenterology and Hepatology and medical director of the Digestive Health Center, at MetroHealth in Cleveland, Ohio, stressed the importance of the findings. “This is a drug that would address the lack of response to PPI treatment,” he said in a press release.

“Specifically, this drug is meant for patients with established gastroesophageal reflux disease who do not respond to PPI therapy that is given once a day,” Fass added.

The multi-center, double-bind, placebo-controlled trial evaluated IW-3718 (Ironwood Pharmaceuticals), a gastric-retentive, extended-release formulation of the bile acid sequestrant colesevelam, as an adjunct to PPI therapy. The study incorporated 280 participants currently on PPI therapy, who were randomly assigned to receive either placebo or IW-3718 at 1 of 3 doses: 500, 1000, or 1500 mg, twice per day, from March 2016 through April 2017.

The study’s primary intention was to observe weekly changes in heartburn severity from baseline to week 8 in patients treated with IW-3718; researchers additionally analyzed percentage change in weekly regurgitation frequency.

Results of the study included a 58% reduction of heartburn severity from baseline to week 8 in patients being administered 1500 mg of IW-3718, and a 17% reduction in regurgitation for participants who received the highest dose of IW-3718 compared with the placebo group.

Although phase 3 trials are ongoing, researchers stressed that IW-3718 is currently only being studied in combination with PPIs rather than as a standalone treatment. Data from phase 3 studies are not yet available.

The study’s researchers plan to include future trials that take a look at the efficacy of IW-3718 in patients with refractory bile acid reflux.

“This type of reflux is most common in patients who have had their gallbladder removed, and I would be curious what percentage of patients this applied to in the refractory group,” said Samuel Giordano, MD, a gastroenterology at Cooper University Health Care in Camden, New Jersey. “It would be interesting to see what the response rate was among that patient subset.”

The study’s results have been published in Gastroenterology.

References:

1. Bile Acids May Have Key Role in Refractory GERD. News Release. Gastroenterology & Endoscopy News; March 25, 2020. https://www.gastroendonews.com/In-the-News/Article/03-20/Bile-Acids-May-Have-Key-Role-in-Refractory-GERD/57702/. Accessed April 29, 2020.