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 will be indicated for treatment of Crohn’s patients. There is currently no other effective, long-term cure for Crohn’s disease. Current standard of care includes 5-ASA agents, corticosteroids, immunomodulating drugs (e.g. Methotrexate) and anti-TNFα (e.g. Remicade, Centocor (J&J)). However, standard care leaves an unmet medical need for a long lasting treatment with low side-effects. RHB-104 holds promise for providing long term remission with reduced side-effects allowing affected patients to lead normal lives. The combination therapy demonstrated promising results in phase II and phase IIIa trials in Australia.
RedHill is expected to commence a Phase III clinical trial in North America and Israel with RHB-104, planned to begin in the third quarter of 2013 and is also planning a European Phase III clinical trial.
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 diagnistic test with Quest Diagnostics.
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*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- Chamberlin. W.; Borody.T.; Naser. S. MAP-associated Crohn’s Disease: MAP, Koch’s postulates, causality and Crohn’s Disease. Digestive and Liver Disease. 2007, Vol 39, PP 792-794.
8- 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.
9- Hruska. K.; Kaevska. M. Mycobacteria in water, soil, plants and air: a review. Veterinarni Medicina. 2012, Vol 57, 12, PP 623-679