RedHill Biopharma Says FDA Accepts IND Application For RHB-105 Phase III Study

(RTTNews) - Israeli-based RedHill Biopharma Ltd. (RDHL) said the U.S. Food and Drug Administration, or the FDA, has accepted its Investigational New Drug or IND application for the ERADICATE Hp study - a Phase III clinical study with RHB-105 for the treatment of Helicobacter pylori bacterial infection. This 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.

The company also said it plans to begin the Phase III study in the U.S. by the end of this month, subject to final preparations. RHB-105 is a new and proprietary combination therapy of two antibiotics and a PPI, 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.

RedHill also noted that it recently commenced another Phase III study in the U.S. with RHB-104 for the treatment of Crohn's disease.