Redhill Biopharma successfully meets primary endpoint in Phase III study of RHB-105 for H. pylori infection

RedHill Biopharma Ltd., an Israeli biopharmaceutical company focused on late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, today announced positive top-line results from its Phase III study with RHB-105 for the treatment of Helicobacter pylori (H. pylori) bacterial infection. 
Top-line results from the study demonstrated 89.4% efficacy in eradicating H. pylori infection with RHB-105.

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 (p <0.001). 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 (CSR), expected in the third quarter of 2015.

Prof. David Graham, M.D., M.A.C.G., of the Baylor College of Medicine, a key opinion leader in the field of gastric cancer and H. pylori infection and Principal Investigator of the ERADICATE Hp study, said: “The outstanding results of the RHB-105 Phase III study, which demonstrated a 89.4% cure rate of H. pylori, are consistent with the hypothesis that this may represent a promise for a new and improved treatment for H. pylori infection, and could significantly contribute to the prevention of gastric cancer, MALT lymphoma and other gastrointestinal diseases and conditions. Given the current high levels of antibiotic resistance and treatment failures with current standard of care therapies, RHB-105 could become, if approved, a best-in-class treatment, improving and potentially saving patients’ lives.”

Ira Kalfus, M.D., RedHill’s Medical Director, added: “On the basis of the clear success of the 
ERADICATE Hp study, and the Fast-Track designation of RHB-105, we look forward to meeting with FDA to discuss the clinical and regulatory path towards marketing approval in the U.S. No new or unexpected safety issues were identified. Efficacy and safety data from this study will be submitted for presentation at an upcoming medical meeting.” Gilead Raday, RedHill’s Senior VP Corporate and Product Development, said: “We are enthusiastic about the strong Phase III top-line results of RHB-105 and its potential benefit to patients. Coupled with the QIDP designation, patent protection and expanded indication, RHB-105 should be well-positioned, if approved, for commercial success as a first-line therapy for the treatment of H. pylori infection. We would like to thank the patients, investigators and service providers who participated in this study”.

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. A total of 118 dyspepsia patients with confirmed H. pylori infection were enrolled and treated in the ERADICATE Hp study, which was conducted in 13 clinical sites in the U.S. Subjects were randomized in a 2:1 ratio to receive either RHB-105 or a placebo, for a period of 14 days, and assessed for the eradication of H. pylori infection 28 to 35 days after completion of treatment and for the protocol-defined primary endpoint of superiority over historical standard of care efficacy levels of 70%.

RHB-105 is a new and proprietary fixed-dose oral combination therapy of two antibiotics and a proton pump inhibitor (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 (MALT) lymphoma. Gastric cancer is the second most common cause of cancer deaths worldwide with approximately 1 million deaths per year, of which 95% are caused by H. pylori and may be preventable. Several countries have already started, or are planning, population-based H. pylori screening and treatment programs designed to eliminate gastric cancer.

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.

RHB-105 was designated by the FDA as a Qualified Infectious Disease Product (QIDP) under the Generating Antibiotic Incentives Now (GAIN) Act, which is intended to incentivize the development of new antibiotic drugs for the treatment of serious or life-threatening infections. The designation allows RedHill to benefit from Fast-Track development status for RHB-105, providing for an expedited development pathway, as well as Priority Review status, potentially leading to a shorter review time by the FDA of a New Drug Application (NDA), if filed. If approved, RHB-105 will also receive an additional five years of U.S. market exclusivity in addition to the standard exclusivity period, for a total of 8 years of market exclusivity.

The 2015 global and U.S. market potential for H. pylori eradication therapies, at current branded prices, was recently estimated at approximately $4.83 billion and $1.45 billion, respectively, and could potentially grow with increasing awareness of the health risks associated with 
H. pylori infection and the benefits of its eradication.