RedHill: First Patient Dosed In Phase III Trial Of RHB-104 For Crohn's Disease

(RTTNews) - RedHill Biopharma Ltd. (RDHL) said the first patient has been recruited and dosed in the MAP US study, a Phase III trial designed to assess the safety and efficacy of fixed-dose RHB-104 in patients with moderately to severely active Crohn's disease.

RHB-104 is a proprietary and potentially groundbreaking combination antibiotic therapy in oral capsule formulation, with potent intracellular, antimycobacterial and anti-inflammatory properties. It is based on increasing evidence supporting the hypothesis that Crohn's disease is caused by the Mycobacterium avium subspecies paratuberculosis infection in susceptible patients.

The randomized, double-blind, placebo-controlled Phase III study is likely to enroll 240 subjects with moderately to severely active Crohn's disease in over 50 clinical sites in the U.S., Canada and Israel. The study's primary endpoint is the state of remission at week 26 in subjects randomized to receive RHB-104, compared to subjects randomized to receive the placebo.

Also, the firm intends to begin a second Phase III study with RHB-104 for Crohn's disease in Europe, following Scientific Advice Meetings with the UK and Swedish pharmaceutical regulatory agencies earlier this year. The MAP Europe trial is planned to begin in the first half of 2014 and to be conducted in parallel with the ongoing MAP US study.