RHB-104 (GI/Inflammation)

RHB-104 is a potentially groundbreaking, proprietary antibiotic combination therapy in oral capsule 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. The RHB-104 formulation was originally developed by Professor Thomas Borody, a leading innovator of therapeutic approaches to treating gastrointestinal tract diseases, who also developed the original triple therapy for peptic ulcer disease associated with H. pylori.

As part of its development efforts for RHB-104, RedHill is developing, in collaboration with Q Squared Solutions, a diagnostic test to aid in detecting the presence of MAP in whole blood. In January 2015 RedHill and Q Squared Solutions concluded a pre-submission meeting with the FDA regarding the development path of a commercial companion diagnostic test for the detection of MAP in Crohn’s disease patients. Further development work on the MAP companion diagnostic is in progress.

RHB-104 is being developed for multiple indications, including :

  • Crohn's disease - a Phase III study for Crohn's disease is ongoing in the U.S., Canada, Europe, Israel, Australia and New Zealand 
  • Multiple sclerosis - a Phase IIa proof of concept study for multiple sclerosis was completed in Israel with encouraging top-line final results announced December 2016