RHB-105 is an antibiotics and proton pump inhibitor (PPI) proprietary drug combination for Helicobacter pylori (H. pylori) infection. RHB-105 was acquired from Sydney-based Giaconda [ASX: GIA] in August 2010.
RHB-105 is an antibiotics and PPI combination planned to be indicated for the first line treatment of H. pylori infections regardless of ulcer status. H. pylori is a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa associated lymphoid tissue (MALT) lymphoma.
In October 2013 RedHill initiated the ERADICATE Hp study – a randomized, double-blind, placebo-controlled Phase III study to evaluate the safety and efficacy of RHB-105 as a first line therapy for H. pylori infection.
Initiation of the Phase III study followed favorable results in a phase II study conducted in Australia, FDA acceptance of the Company’s IND application and Institutional Review Board (IRB) approval, and is supported by the 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.
H. pylori has recently been added to the FDA’s list of “qualifying pathogens” under the Generating Antibiotic Incentives Now (GAIN) Act. As a result, new drugs indicated to treat H. pylori may be designated as a Qualified Infectious Diseases Product (QIDP) and receive an additional five years of exclusivity, along with fast track status and priority review by the FDA.