Ironwood Pharmaceuticals has commenced two Phase III clinical trials to examine the safety and efficacy of IW-3718 in patients with persistent gastroesophageal reflux disease (GERD).
Both the randomised, double-blind, placebo-controlled, multicentre trials aim to enrol a total of around 1,320 patients with persistent GERD who demonstrate evidence of pathological acid reflux.
Patients will be equally distributed in the trials and will continue to take proton pump inhibitors (PPIs).
They will be randomised to receive placebo or IW-3718 1,500mg twice a day for eight weeks.
The trial's primary objective is overall heartburn responder, defined as a patient who experiences at least a 45% reduction from baseline in heartburn severity for at least four out of eight weeks, including at least one of the last two weeks.
Its secondary objectives are change in weekly heartburn severity, change in weekly regurgitation frequency and the proportion of heartburn-free days.
Ironwood Pharmaceuticals global development senior vice-president and chief development officer Christopher Wright said: “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 PPIs.”
Patients with persistent GERD continue to experience symptoms such as heartburn and regurgitation despite being treated with PPIs.
Nearly ten million people in the US are currently estimated to be affected by the disease.
Ironwood’s IW-3718 is a new, gastric retentive formulation of colesevelam, a bile acid sequestrant.
It is developed to provide the bile acid sequestrant to the stomach over an extended period where it is positioned to capture bile before it reaches the oesophagus.