Date: 2014-06-26
Type of information: Preclinical data
phase: preclinical
Announcement: preclinical data
Company: RedHill Biopharma (Israel)
Product: RHB-104
Action
mechanism: Currently in a Phase III study for the treatment of Crohn\'s disease, RHB-104 is a proprietary and potentially groundbreaking antibiotic combination therapy administered by oral capsule, 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. Several clinical trials were conducted with earlier formulations of the drug, including an Australian Phase III study published by Pfizer and other studies, both with earlier formulations and the current formulation of the drug. RHB-104 is covered by several issued and pending patents.
Disease: type 1 diabetes
Therapeutic area: Metabolic diseases
Country:
Trial details:
Latest
news: * On June 26, 2014, Redhill Biopharma announced positive preliminary pre-clinical data with RHB-104 for the treatment of type 1 diabetes. In light of the preliminary positive data, and subject to the final results and an independent report expected in the coming weeks, the Company is currently assessing the next steps in the development program, including a possible Phase II proof of concept clinical study for type 1 diabetes. The pre-clinical study was designed to evaluate the potential therapeutic effects of RHB-104 using a pre-clinical diabetes model when administered orally. The preliminary data from the pre-clinical study suggests that RHB-104 is effective in treating type 1 diabetes in the study, as measured by blood glucose levels and body weight. Final results and an independent report are expected in the coming weeks. A Phase III study with RHB-104 for Crohn\'s disease is in progress in the U.S., Canada and Israel, and a second Phase III study is planned to commence during the second half of 2014 in Europe. A Phase II proof of concept clinical study with RHB-104 for the treatment of multiple sclerosis (MS) is in progress, following several positive pre-clinical studies in MS and other autoimmune disease models, including rheumatoid arthritis (RA) and Lupus.
