RHB-104 (Crohn’s)

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 the U.S., Canada, Israel, Australia, New Zealand and Europe. A second Phase III trial, in Europe, is planned to commence during the second half of 2014. 


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 (Mycobacterium avium paratuberculosis) in whole blood. In January 2015 RedHill and Quest Diagnostics 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. Following the constructive FDA meeting, RedHill intends to initiate a study of approximately 40 Crohn’s disease patients to assess the clinical utility of the companion diagnostic test during the second or third quarter of 2015.


*Selected references:

1- Greenstein. R.J. Is Crohn’s disease caused by a mycobacterium? Comparisons with leprosy, tuberculosis, and Johne’s disease. THE LANCET Infectious Diseases 2003, Vol 3, PP 507-514.
2- Behr. A. M.; Kapur. V. The evidence for Mycobacterium paratuberculosis in Crohn’s disease. Current Opinion in Gastroenterology. 2008, Vol 24, PP 17–21.

3- Borody T.J.; Leis. S.; Warren. E.F.; Surace. R. Treatment of severe Crohn’s disease using antimycobacterial triple therapy–approaching a cure? Digestive and Liver Disease 2002, Vol 34, 1, PP 29-38.
4- Taylor, J. H. Treatment with drugs active against Mycobacterium avium subspecies paratuberculosis can heal Crohn’s disease: more evidence for a neglected Public Health tragedy. Digestive and Liver Disease. 2002, Vol 34, PP 9-12.
5- Borody. T.J.; Bilkey. S.; Wettstein. A. R.; Leis. S.; Pang. G.; Tye. S.; Anti-mycobacterial therapy in Crohn’s disease heals mucosa with longitudinal scars
Digestive and Liver Disease. 2007, Vol 39, 5, PP 438-44.

6- Chamberlin. W.; Ghobrial. G.; Chehtane. M.; Naser. S. A. Successful Treatment of a Crohn’s Disease Patient Infected with Bacteremic Mycobacterium Paratuberculosis. American Journal of Gastroenterol. 2007, Vol 102, PP 689-691.

7- Kirkwood. C.D.; Wagner. J.; Boniface. K.; Vaughan. J.; Michalski. W. P.; Catto-Smith. A. J.; Cameron. Don .J.S.; Bishop. R. F.Mycobacterium avium subspecies paratuberculosis in children with early-onset Crohn’s disease. Inflammatory Bowel Diseases. 2009, Vol 15, 11, PP 1643-1655.

8- Hruska. K.; Kaevska. M. Mycobacteria in water, soil, plants and air: a review. Veterinarni Medicina. 2012, Vol 57, 12, PP 623-679