This article is more than 5 years old. Information may no longer be current.
Phase 3 trials to test efficacy, safety of bile acid sequestrant for GERD
Click Here to Manage Email Alerts
Two phase 3 trials are set to test the efficacy and safety of IW-3718 — a novel formulation of the bile acid sequestrant colesevelam — for treating GERD, according to the manufacturer Ironwood Pharmaceuticals.
The company touts the drug as a potential therapy for patients who continue to experience symptoms of GERD despite receiving the current standard of care.
“Pre-clinical and clinical evidence suggest that IW-3718 may offer a treatment option for the millions of patients with GERD who continue to experience frequent and bothersome symptoms such as heartburn and regurgitation despite taking [proton pump inhibitors],” Christopher Wright, MD, PhD, senior vice president of global development and chief development officer of Ironwood said in a press release. “Our teams have done excellent work to rapidly initiate these trials. We are hopeful that these studies will generate data in support of a potential approval as quickly as possible.”
The identical, randomized, double-blind trials are slated to include a total 1,320 patients with persistent GERD who show signs of pathological acid reflux. Patients will continue taking PPIs and receive either 1,500 mg of IW-3718 or placebo twice a day for eight weeks, according to the press release.
Researchers have set a primary endpoint of overall heartburn response defined as a heartburn severity reduction of at least 45% for at least 4 of 8 weeks. They will also investigate the secondary endpoints of change in weekly heartburn severity, change in weekly regurgitation frequency and the proportion of heartburn-free days.
The drug was previously tested in a phase 2b trial on 282 patients with persistent GERD. Data from that study presented at Digestive Disease Week showed that patients who took IW-3718 experienced significantly improved heartburn severity scores compared with placebo (P = .04), as well as improved regurgitation scores (P = .01).
Disclosures: Wright is employed by Ironwood Pharmaceuticals.