RHB-104 is a proprietary antibiotics drug combination for treatment of Crohn’s disease.* RHB-104 was acquired from Sydney-based Giaconda [ASX: GIA] in August 2010.
RHB-104 is a proprietary and potentially groundbreaking combination therapy in oral pill formulation, with potent intracellular, antimycobacterial and anti-inflammatory properties. RHB-104 is based on increasing evidence supporting the hypothesis that Crohn’s disease is caused by the Mycobacterium avium subspecies paratuberculosis(MAP) infection in susceptible patients rather than being an autoimmune disease. Current therapies for Crohn’s disease target symptomatic relief, are widely considered to be of limited efficacy in the long term, and are associated with numerous side effects.
The RHB-104 formulation was originally developed by Professor Thomas Borody, a leading innovator of therapeutic approaches to gastrointestinal tract diseases.
Several clinical trials were conducted with earlier formulations of the drug, including two Phase II studies, an Australian Phase III study and several supplementary studies. The formulation of RHB-104 is covered by several issued and pending patents.
In September 2013 RedHill initiated a first Phase III clinical trial with RHB-104 for Crohn’s Disease in North America and Israel. A second Phase III trial, in Europe, is planned to commence in the first half of 2014.
RedHill further acquired an exclusive license from the University of Central Florida Research Foundation, Inc. to a patent-protected diagnostic test for the detection of MAP (Mycobacterium avium paratuberculosis) bacterium, and is developing the diagnostic test with Quest Diagnostics.
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