RedHill's RHB-104 Combination Shows 80% Remission In Pediatric Crohn's Study

(RTTNews) - RedHill Biopharma Ltd. (RDHL) reported the presentation of a poster at the American College of Gastroenterology 2013 Annual Scientific Meeting on October 14, 2013, and the pending publication in the American Journal of Gastroenterology, of positive results from an independent, single-center, retrospective study with 10 pediatric patients suffering from Crohn's disease, an inflammatory disease of the gastrointestinal system with significant unmet medical need.

The study, which was conducted by Professor Thomas Borody at the Centre for Digestive Diseases in Sydney, Australia, targeted at assessing the safety and efficacy of the anti-MAP combination therapy to treat Crohn's disease in pediatric patients. The company said the patients were treated with an earlier formulation of RedHill's RHB-104 anti-MAP combination therapy, using the same active ingredients in doses adjusted for pediatric usage.

The result of the retrospective Australian trial showed a clinical remission rate of 80% in 10 pediatric Crohn's disease patients, aged 8 to 17, treated for six to 117 months. The state of remission was evaluated and recorded regularly throughout treatment and was defined as Pediatric Crohn's Disease Activity Index <10 for a minimum of three months, with stable, or reduction in, preexisting Crohn's disease medications.

RHB-104 is a proprietary and potentially groundbreaking combination antibiotic therapy in oral pill formulation, with potent intracellular, antimycobacterial and anti-inflammatory properties.

Recently, RedHill has begun a Phase III trial in the U.S. with RHB-104 for Crohn's disease treatment in adult patients, and a second Phase III study is planned to begin in Europe by mid-2014.