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.
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.