RedHill Meets Primary Endpoint In Phase III Study Of RHB-105 For H. Pylori

(RTTNews) - RedHill Biopharma Ltd. (RDHL) announced positive top-line data from its Phase III study with RHB-105 for the treatment of Helicobacter pylori or H. Pylori bacterial infection. Top-line results from the study demonstrated 89.4% efficacy in eradicating H. pylori infection with RHB-105.

According to the company, the ERADICATE Hp first Phase III study successfully met its primary endpoint of superiority over historical standard of care efficacy levels of 70%, with high statistical significance. No serious adverse events, new or unexpected safety issues were noted in the study.

The top-line results from the RHB-105 Phase III study, demonstrating achievement of primary endpoint, were provided to RedHill by an independent third party following an independent analysis and remain subject to completion of the independent review and analysis of the underlying data, including all safety, secondary and other outcome measures, and completion of the clinical study report or CSR, expected in the third quarter of 2015.

The randomized, placebo-controlled, ERADICATE Hp Phase III study was designed to evaluate the safety and efficacy of RHB-105 as a first-line treatment for confirmed H. pylori infection.

RHB-105 is a new and proprietary fixed-dose oral combination therapy of two antibiotics and a proton pump inhibitor or PPI in an all-in-one oral capsule with a planned indication for the treatment of H. pylori infection - a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa associated lymphoid tissue or MALT lymphoma.

With RHB-105, RedHill is pursuing an indication of first-line treatment of H. pylori infection, regardless of ulcer status, a significantly broader indication than current standard treatments for H. pylori, which are typically indicated only in patients with active or recent history of duodenal ulcer disease. If approved, RHB-105 may be the first H. pylori eradication therapy to target this broader indication, which would significantly expand the potential patient population for this drug candidate. The ERADICATE Hp Phase III study is planned to be followed by a second Phase III study and additional studies may be required, subject to FDA feedback.