RHB-105 (H. pylori)
RHB-105 is a new and proprietary fixed-dose oral combination therapy of two antibiotics and a proton pump inhibitor (PPI) in an all-in-one oral capsule with a planned indication for treatment of Helicobacter pylori (H. pylori) infection.
H. pylori bacterial infection is a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa associated lymphoid tissue (MALT) lymphoma.
RHB-105 completed a first Phase III study for the treatment of Helicobacter pylori (H. pylori) bacterial infection, named the ERADICATE Hp study.
The ERADICATE Hp first Phase III study with RHB-105 successfully met its primary endpoint of superiority over historical standard of care efficacy levels of 70%, with high statistical significance (p <0.001). No serious adverse events, new or unexpected safety issues related to the drug were noted in the study.
The results from the study demonstrated 89.4% efficacy in eradicating H. pylori infection with RHB-105.
RedHill met with the FDA to discuss the successful results of the recently completed first Phase III study with RHB-105 (the ERADICATE Hp study) and the proposed design of the confirmatory Phase III study for the treatment of H. pylori infection. As a result of the productive and supportive feedback received from the FDA, RedHill intends to complete the design of the planned confirmatory Phase III randomized, double-blind, active comparator, two-arm clinical study, comparing RHB-105 against a high dose amoxicillin and omeprazole regimen.
The ERADICATE Hp Phase III study is registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health which provides public access to information on publicly and privately supported clinical studies.
The ERADICATE Hp Phase III study followed favorable results in a phase II study conducted in Australia and is supported by positive results from a PK study concluded with RHB-105 in December 2013.
Following discussions with the FDA, RedHill announced in August 2014 that it had received authorization from the FDA to pursue a new and significantly broader indication with RHB-105. While current standard treatments for H. pylori are typically indicated to treat patients with active or recent history of ulcers, RHB-105’s new intended indication will target H. pylori infection as a first line treatment regardless of ulcer status.
RHB-105 was granted Qualified Infectious Disease Product (QIDP) designation by the U.S. FDA in November 2014. The QIDP designation was granted under the FDA’s Generating Antibiotic Incentives Now (GAIN) Act, which is intended to encourage development of new antibiotic drugs for the treatment of serious or life-threatening infections. The QIDP designation allows RHB-105 to benefit from fast-track development status with an expedited development pathway and from priority review status which provides for a shorter review time by the FDA of a future potential marketing application. If approved, RHB-105 will also receive an additional five years of U.S. market exclusivity on top of the standard exclusivity period, for a total of 8 years.
RedHill acquired RHB-105 from Sydney-based Giaconda [ASX: GIA] in August 2010. The RHB-105 combination was originally developed as a next-generation therapy 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.