RedHill Begins Patient Screening In Phase III Eradicate Hp Study

(RTTNews) - RedHill Biopharma Ltd. (RDHL) Wednesday said it started the patient screening process in the 'Eradicate Hp study', which is a Phase III clinical study in the U.S. designed to evaluate the safety and efficacy of RHB-105 as a first-line treatment for confirmed Helicobacter pylori bacterial infection.

The trial is expected to enroll 90 subjects with confirmed H. pylori infection and non-investigated dyspepsia in up to ten clinical sites. The study's primary endpoint is eradication of H. pylori infection at 28 to 56 days after completion of treatment. The data is expected in the second half of 2014.

The company said that a supporting pharmacokinetic study of the RHB-105 formulation has began in October. Also, the comapny is in talks with the FDA with respect to RHB-105's planned indication.

Further, RedHill said a second Phase III study with RHB-104, for the treatment of Crohn's disease is planned to commence in Europe by mid-2014.