RedHill:First Patient Dosed In PhaseIII Study Of RHB-105 For H. Pylori Infection

(RTTNews) - RedHill Biopharma Ltd. (RDHL) announced that the first patients have been dosed in the Phase III ERADICATE Hp clinical study in the U.S.

The Phase III ERADICATE Hp clinical 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.

Reza Fathi, RedHill's Senior VP R&D said, "A previous Phase II study conducted with the RHB-105 combination demonstrated an eradication rate of more than 90% in patients who had previously failed standard of care therapy. This positive data leads us to believe that, if approved, RHB-105 could become the preferred first line therapy for H. pylori infection. Considering that per patient treatment is only 14 days, we expect data from the ongoing Phase III study to be available by the third quarter of 2014."

The randomized, double-blind, placebo-controlled, Phase III study is expected to enroll 90 non-investigated dyspepsia subjects with confirmed H. pylori infection in 8 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.

RHB-104 is a combination antibiotic therapy in oral capsule formulation, with potent intracellular, antimycobacterial and anti-inflammatory properties. It is a potentially groundbreaking therapy that targets the suspected underlying cause of the disease, based on increasing evidence supporting the hypothesis that Crohn's disease is caused by the Mycobacterium avium subspecies paratuberculosis (MAP) infection in susceptible patients.