Date: 2017-01-10
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
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. RHB-105 was granted Qualifying Infectious Disease Product (QIDP) designation by the FDA, providing a Fast-Track development pathway, as well as NDA Priority Review status, potentially leading to a shorter NDA review time by the FDA, if filed. If approved, RHB-105 is entitled, thanks to its QIDP status, to receive an additional five years of U.S. market exclusivity, in addition to the standard exclusivity period, for a total of 8 years of U.S. market exclusivity.
Disease: Helictobacter pylori infection
Therapeutic area: Infectious diseases
Country:
Trial details:
Latest
news: * On January 10, 2017, RedHill Biopharma announced first dosing in a three-way crossover pharmacokinetic (PK) study with RHB-105 in 18 subjects (healthy volunteers), intended to evaluate the bioavailability (BA) of RHB-105 actives versus the comparator in the planned confirmatory Phase III study (dual therapy of amoxicillin and omeprazole) and a food-effect study with RHB-105. These PK studies are intended to support the planned confirmatory Phase III study with RHB-105, a proprietary, fixed-dose, oral combination therapy for the eradication of H. pylori infection. The two-arm, randomized, double-blind, active comparator confirmatory Phase III study, comparing RHB-105 against a dual therapy amoxicillin and omeprazole regimen at equivalent doses, is planned to be initiated by April of 2017, after completion of the ongoing supportive PK program and submission of clinical study reports to the FDA. The confirmatory Phase III study is planned to enroll approximately 440 patients in up to 55 clinical sites in the U.S. The planned confirmatory Phase III study, along with the results from the successfully completed first Phase III study with RHB-105 (the ERADICATE Hp study) and data to be obtained from the ongoing supportive PK program, are expected to support a U.S. New Drug Application (NDA) for RHB-105. RedHill is pursuing with RHB-105 an indication of first-line treatment of H. pylori infection, regardless of ulcer status, a significantly broader indication than current standard treatments for H. pylori, which are typically indicated only for patients with active or recent history of duodenal ulcer disease. If approved, RHB-105 may be the first H. pylori eradication therapy in the U.S. to target this broader indication, which would significantly expand the potential patient population for this drug candidate.
