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 Quest Diagnostics, a diagnostic test to aid in detecting the presence of MAP in whole blood.

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
  • NTM (Nontuberculous Mycobacteria) infections - RHB-104 was granted QIDP status for the treatment of NTM. RedHill plans, subject to regulatory approvals, to initiate a pivotal Phase III study in the U.S. with RHB-104 for NTM infections