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RedHill Biopharma Initiates Phase III Study Of RHB-105 For H. Pylori Infection

  • RedHill has initiated the patient screening process in the ERADICATE Hp study - a randomized, double-blind, placebo-controlled Phase III study to evaluate the safety and efficacy of RHB-105 as a first-line therapy for H. pylori bacterial infection
  • Subjects will be treated with RHB-105 for a period of 14 days in up to 10 clinical sites in the U.S. and assessed for the primary endpoint of eradication of H. pylori infection 28 to 56 days after completion of treatment, with data expected by the second half 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 high failure rates due to growing H. pylori resistance
  • RedHill recently commenced a Phase III study in the U.S. with another treatment for a digestive system condition - RHB-104 for Crohn's disease

TEL-AVIV, Israel, Oct. 30, 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 it has initiated the patient screening process in the ERADICATE Hp study - a Phase III clinical study in the U.S. designed to evaluate the safety and efficacy of RHB-105 as a first-line treatment for confirmed Helicobacter pylori ( H. pylori) bacterial infection. Initiation of the RHB-105 Phase III clinical study follows the necessary approvals including FDA acceptance of the Company's Investigational New Drug (IND) application and Institutional Review Board (IRB) approval.

RHB-105 is a new and proprietary fixed-dose combination therapy of two antibiotics and a proton pump inhibitor (PPI), in an all-in-one oral capsule, designed for the treatment of H. pylori bacterial infection - a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa associated lymphoid tissue (MALT) lymphoma. The RHB-105 combination was originally developed by Professor Thomas Borody, a leading innovator of therapeutic approaches to gastrointestinal tract diseases. Prof. Borody, a member of RedHill's Advisory Board, also developed the first triple therapy for H. pylori associated with peptic ulcer disease.

The randomized, double-blind, placebo-controlled Phase III study is expected to enroll 90 subjects with confirmed H. pylori infection and non-investigated dyspepsia in up to ten clinical sites in the U.S. Subjects will be 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 will be assessed for the study's primary endpoint of eradication of H. pylori infection 28 to 56 days after completion of treatment.

Existing standard of care combination therapies for H. pylori infection have high failure rates due to 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 demonstrated superior resistance profile, and offers a new and potentially improved therapeutic alternative with increased efficacy in eradicating H. pylori infection.

A Phase II study conducted in Australia with the RHB-105 active agents demonstrated an eradication rate greater than 90% in patients who had previously failed at least one course of standard of care therapy for 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 overall patient compliance and response.

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