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The first patients have been dosed in the ERADICATE Hp study - a randomized, double-blind, placebo-controlled, Phase III study evaluating RHB-105 as a first-line therapy for H. pylori bacterial infection
Seven of the eight clinical sites in the U.S. are actively enrolling patients, with the last site expected to commence enrollment shortly; the Phase III data is expected by the third quarter of 2014
Approximately two-thirds of the world's population is infected with H. pylori, a major cause of chronic gastritis, peptic ulcer disease and gastric cancer; existing therapies have increasing failure rates due to bacterial resistance
RedHill recently commenced dosing in a Phase III study with a different drug, RHB-104, for Crohn's disease, another inflammatory disease of the gastrointestinal system
TEL-AVIV, Israel, Dec. 17, 2013 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) (the "Company" or "RedHill"), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, proprietary formulations and combinations of existing drugs, today 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.
"We are very excited by the dosing of the first patients in the Phase III study with RHB-105 for the treatment of
H. pylori infection. We believe RHB-105 is a potential solution to the growing bacterial resistance and high failure rates of currently available therapies,"
said Dr. Reza Fathi, RedHill's Senior VP R&D. Dr. Fathi continued, "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."
Existing standard of care combination therapies for
H. pylori infection have increasingly high failure rates due to the growing resistance of
H. pylori to the antibiotics commonly used in such therapies. RHB-105 is composed of a different combination of antibiotics, specifically selected due to their potential for improved efficacy and superior resistance profile for eradicating
H. pylori infection.
In addition to a potential increase in efficacy, RHB-105's new and proprietary all-in-one oral capsule formulation offers a convenient treatment regimen, potentially improving patient compliance and convenience.