RedHill Biopharma Ltd. 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. The Phase I study with RHB-104, conducted in Canada, is the first of several pharmacokinetic (PK) studies which the Company plans to conduct as part of the RHB-104 development program. The additional PK studies are designed to satisfy regulatory requirements for future potential marketing applications, and include a long-term population PK study as part of the RHB-104 MAP US Phase III study for Crohn's disease, as well as a drug-drug interaction study to be conducted in parallel to the clinical studies currently underway with RHB-104.

The preliminary results from the Phase I study support the safety profile of the RHB-104 proprietary all-in-one combination therapy and provide further insight into the pharmacokinetic properties of this drug. This is the first of several pharmacokinetic studies designed to satisfy regulatory requirements for potential future marketing applications in a number of countries. The additional pharmacokinetic studies will be conducted in parallel to the ongoing RHB-104 clinical trials.

Enrollment continues in both the Phase III study in Crohn's disease and the Phase IIa proof of concept study in multiple sclerosis, and it expect the safety data to contribute to future planned marketing applications for this potentially groundbreaking drug.