RedHill Biopharma Ltd. (RDHL) announced that the first patient has been dosed in the phase III ERADICATE Hp study. This study evaluates the safety and efficacy of RHB-105 as a first-line treatment for confirmed Helicobacter pylori (H. pylori) bacterial infection.
The randomized, double-blind, placebo-controlled, phase III study is expected to enrol 90 subjects. These patients will be randomized in a 2:1 ratio to receive either RHB-105 or placebo for a period of 14 days.
The primary endpoint of the study is the eradication of H. pylori infection in a span of 28 to 56 days after completion of treatment. RedHill Biopharma expects data from this study by the third quarter of 2014.
H. pylori is a major cause of chronic gastritis, peptic ulcer disease and gastric cancer; and mucosa associated lymphoid tissue (MALT) lymphoma. As per the company, H. pylori affects two-thirds of the world’s population.
RedHill Biopharma has another interesting candidate in RHB-104. In Nov 2013, the company commenced a double-blind, placebo-controlled, phase III MAP U.S. study on RHB-104 for the treatment of Crohn's disease. Apart from Crohn’s disease, RedHill Biopharma is also evaluating the candidate for the treatment of multiple sclerosis (phase IIa proof of concept trial is going on) and rheumatoid arthritis (plans for a phase IIa proof of concept trial), and systemic lupus erythematosus.
RedHill Biopharma carries a Zacks Rank #2 (Buy). Some better-ranked stocks include Questcor Pharmaceuticals Inc. (QCOR), Actelion Ltd. (ALIOF) and Jazz Pharmaceuticals plc (JAZZ). Each stock carries a Zacks Rank #1 (Strong Buy).
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