RedHill Biopharma Ltd. (NASDAQ: RDHL) (Tel-Aviv Stock Exchange: 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 initiation of a confirmatory Phase III study with RHB-105, newly branded as TALICIA™(1), for the treatment of H. pylori infection (the ERADICATE Hp 2 study).

TALICIA™ (RHB-105) is a proprietary, fixed-dose, oral combination therapy of two antibiotics and a proton pump inhibitor (PPI) in an all-in-one oral capsule for the eradication of H. pylori infection.

The two-arm, randomized, double-blind, active comparator confirmatory Phase III ERADICATE Hp 2 study will compare TALICIA™ (RHB-105) against a dual therapy amoxicillin and omeprazole regimen at equivalent doses. The study is planned to enroll 444 non-investigated dyspepsia patients with confirmed H. pylori infection in up to 65 clinical sites in the U.S. Subjects will be randomized in a 1:1 ratio to receive four capsules, three times daily, of either TALICIA™ (RHB-105) or the active comparator, for a period of 14 days. Subjects will be assessed for the study’s primary endpoint of eradication of H. pylori infection at 42 through 70 days after initiation of treatment.

Subject to its successful outcome and any additional regulatory feedback, the confirmatory Phase III study, along with the results from the successfully completed first Phase III study with TALICIA™ (RHB-105) (the ERADICATE Hp study) and data from the completed supportive PK program, are expected to support a potential U.S. New Drug Application (NDA) for TALICIA™ (RHB-105).

The first Phase III study with TALICIA™ (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 TALICIA™ (RHB-105). Notably, the 89.4% efficacy in eradicating H. pylori infection with TALICIA™ (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 TALICIA™ (RHB-105) as a treatment for H. pylori infection. Treatment with TALICIA™ (RHB-105) appeared to be safe and well tolerated.

TALICIA™ (RHB-105) was granted Qualifying Infectious Disease Product (QIDP) designation by the U.S. Food and Drug Administration (FDA), providing a Fast-Track development pathway, as well as NDA Priority Review status, potentially leading to a shorter NDA review time by the FDA, if filed. If approved, TALICIA™ (RHB-105) is entitled to receive, thanks to its QIDP status, an additional five years of U.S. market exclusivity, in addition to the standard exclusivity period, for a total of 8 years of U.S. market exclusivity.

RedHill is pursuing with TALICIA™ (RHB-105) 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 for patients with active or recent history of duodenal ulcer disease. If approved, TALICIA™ (RHB-105) may be the first H. pylori eradication therapy in the U.S. to target this broader indication, which would significantly expand the potential patient population for this drug candidate.

H. pylori bacterial infection is a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa-associated lymphoid tissue (MALT) lymphoma. H. pylori infection is estimated to affect over half of the adult population worldwide(2). The growing resistance of the H. pylori bacteria to metronidazole and clarithromycin has resulted in increasing failure rates of current SoC for H. pylori eradication, reaching an estimated 30%(3). Despite the strong unmet medical need, no new drug has been approved by the FDA for this indication in over a decade. The World Health Organization (WHO) recently published a global priority list of 12 life-threatening multidrug-resistant bacteria, in which H. pylori infection was classified as a high-priority bacteria for which new treatments are urgently needed(4).

The 2015 global and U.S. market potential for H. pylori eradication therapies at branded prices, were 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(5).

The confirmatory Phase III ERADICATE Hp 2 study with TALICIA™ (RHB-105) will be registered on www.ClinicalTrials.gov, a web-based service of the U.S. National Institutes of Health, which provides access to information on publicly and privately supported clinical studies.