RedHill Begins Dosing Gastritis Trial

RedHill Biopharma has dosed the first patients in the Phase III ERADICATE Hp clinical study in the U.S. The study is designed to evaluate the safety and efficacy of RHB-105 as a first-line treatment for confirmed Helicobacter pylori (H. pylori) bacterial infection, a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa associated lymphoid tissue (MALT) lymphoma. Seven of the eight clinical sites in the U.S. have commenced enrollment of patients for the ERADICATE Hp study, and the last site is expected to commence enrollment shortly. Data is expected by 3Q14.

A previous Phase II study conducted with RHB-105, a new and proprietary fixed-dose combination therapy of two antibiotics and a proton pump inhibitor (PPI) in an all-in-one oral capsule, demonstrated an eradication rate of more than 90% in patients who had previously failed standard of care therapy. The treatment requires 14 days of treatment, and RedHill is optimistic that, if approved, the treatment could become the preferred first line therapy for H. pylori infection.

The randomized, double-blind, placebo-controlled study is expected to enroll 90 non-investigated dyspepsia subjects with confirmed H. pylori infection in eight clinical sites in the U.S. Subjects are randomized in a 2:1 ratio to receive four capsules three times daily of either RHB-105 or placebo for a period of 14 days, and are assessed for the study’s primary endpoint of eradication of H. pylori infection 28 to 56 days after completion of treatment.