Date: 2016-04-18
Type of information: Initiation of preclinical development
phase: 3
Announcement:
Company: RedHill Biopharma (Israel)
Product: RHB-105 (amoxicillin, rifabutin and omeprazole)
Action
mechanism: antibiotic/ proton pump inhibitor. RHB-105 is a new and proprietary fixed-dose combination therapy of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole), 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, who developed the first approved triple therapy treatment for H. pylori associated with peptic ulcer disease.
Disease: H. pylori infection
Therapeutic area: Infectious diseases
Country: USA
Trial details:
Latest
news: * On April 18, 2016, Redhill Biopharma announced that the FDA has confirmed, subject to final minutes of the meeting, the planned two-arm, randomized, double-blind, active comparator design of the confirmatory Phase III study with RHB-105 for the treatment of H. pylori infection, expected to be initiated in the second half of 2016
Based on FDA feedback, and subject to successful completion, the planned confirmatory Phase III study, along with the successfully completed first Phase III study and data from a supportive PK program, are expected to support a U.S. New Drug Application (NDA) for RHB-105. The first Phase III study with RHB-105 successfully demonstrated 89.4% efficacy in eradicating H. pylori infection with RHB-105 (p<0.001), supporting the potential superior efficacy of RHB-105 over current standard-of-care (SoC) therapies. As per FDA recommendation, RedHill will complete a supportive pharmacokinetic (PK) program prior to initiating the confirmatory Phase III study in the second half of 2016. Subject to a successful outcome, the confirmatory Phase III study and supportive PK program are expected to complete the clinical package required for a U.S. New Drug Application (NDA) for RHB-105.
