RedHill Biopharma Announces FDA Acceptance Of IND Application For RHB-105 (H. Pylori) Phase III Study - To Commence Shortly

  • The Phase III study is expected to commence in the U.S. by the end of this month
  • RHB-105 is a new and proprietary combination therapy in an oral capsule for the treatment of H. pylori bacterial infection
  • RedHill recently commenced another Phase III study in the U.S. with RHB-104 for the treatment of Crohn's disease

TEL-AVIV, Israel, Oct. 22, 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, announced today that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for the ERADICATE Hp study - a Phase III clinical study with RHB-105 for the treatment of Helicobacter pylori ( H. pylori) bacterial infection. The Company plans to commence the Phase III study in the U.S. by the end of this month, subject to final preparations.

The RHB-105 IND acceptance follows a pre-IND meeting held with the FDA in October 2012 and subsequent communications between the Company and the FDA throughout the past year. RHB-105 is a new and proprietary combination therapy of two antibiotics and a PPI (proton pump inhibitor), in an 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.

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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