RHB-104 is a proprietary antibiotics drug combination for treatment of Crohn’s disease.
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 first half of 2013 and is also planning a European Phase III clinical trial.