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Preliminary positive safety results received from a Phase I study with RHB-104 in 84 healthy adult subjects
Additional PK studies with RHB-104 are planned, including long-term population PK and drug-drug interaction studies, to support potential future marketing applications
TEL-AVIV, Israel, Jan. 6, 2014 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE: RDHL) (the "Company" or "RedHill"), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, proprietary formulations and combinations of existing drugs, today reported preliminary positive results from a Phase I study with RHB-104, a proprietary combination antibiotic oral capsule formulation for the treatment of Crohn's disease, currently undergoing a Phase III study in the U.S., with additional clinical sites planned in Canada and Israel (the MAP US study).
The single dose two-way crossover comparative Phase I study included 84 healthy male and female subjects ages 18-45 and was designed to evaluate the effect of co-administration of food on the pharmacokinetics of the constituent components of RHB-104 and two metabolites. The secondary objective of this study was to assess the safety and tolerability of RHB-104 under fed and fasting conditions.
Preliminary pharmacokinetic (of the first 28 subjects) and safety (of all 84 subjects) data have been evaluated. A food effect was demonstrated with the administration of RHB-104, suggesting higher bioavailability with food. There were no serious adverse events reported, and overall safety between fed and fasted subjects was comparable. This preliminary data supports the RHB-104 MAP US Phase III study for Crohn's disease currently underway in the U.S. and the Phase IIa proof of concept study for multiple sclerosis currently underway in Israel. RHB-104 is administered with food in these two studies.
The preliminary results of the Phase I study, including the pharmacokinetics, bioavailability and safety of RHB-104, are subject to further analysis and final quality control. An independent clinical study report is expected in the coming weeks from the clinical research organization (CRO) which conducted the study.