RedHill Biopharma Announces Poster Presentation of the Positive RHB-105 Phase III Results for H. pylori Infection at Digestive Disease Week 2017
TEL-AVIV, Israel, May 04, 2017 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (RDHL) (RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today announced the presentation of a poster at Digestive Disease Week (DDW) 2017. The poster (presentation number: Sa1200) will be presented by Ira Kalfus, MD, Medical Director at RedHill, on Saturday, May 6, 2017 from 12:00 PM to 2:00 PM CDT, in Chicago, IL.
The poster1 presentation, entitled “ERADICATE Hp: A Randomized, Double-Blind, Placebo-Controlled Phase III Study to Assess the Safety and Efficacy of Rifabutin Triple Therapy (RHB-105) for Helicobacter pylori (H. pylori) Infection in Dyspepsia Patients” describes the previously reported positive final results of the ERADICATE Hp first Phase III study with RHB-105 for H. pylori infection.
RHB-105 is a proprietary, fixed-dose, oral combination therapy for the eradication of H. pylori infection.
The ERADICATE Hp first Phase III study with RHB-105 successfully met its protocol-defined mITT primary endpoint of superiority over historical standard-of-care (SoC) eradication rate of 70%, with high statistical significance (p<0.001). The study results demonstrated 89.4% efficacy in eradicating H. pylori infection with RHB-105. Notably, the 89.4% efficacy in eradicating H. pylori infection with RHB-105 was also superior to subsequent open-label treatment with SoC therapies of patients in the placebo arm of the ERADICATE Hp study, which demonstrated 63% eradication rate in the mITT population (p=0.006), further supporting the potential efficacy of RHB-105 as a treatment for H. pylori infection. Treatment with RHB-105 appeared to be safe and well tolerated.
A confirmatory Phase III study is planned to be initiated in the second quarter of 2017. The two-arm, randomized, double-blind, active comparator confirmatory Phase III study will compare RHB-105 against a dual therapy amoxicillin and omeprazole regimen at equivalent doses. The study is planned to enroll approximately 440 patients in up to 55 clinical sites in the U.S.
Subject to its successful completion, the planned confirmatory Phase III study, along with the results from the successfully completed first Phase III ERADICATE Hp study with RHB-105 and data to be obtained from an ongoing supportive PK program, are expected to support a U.S. New Drug Application (NDA) for RHB-105.
