RedHill Biopharma Ltd. announced first dosing in a three-way crossover pharmacokinetic study with RHB-105 in 18 subjects intended to evaluate the bioavailability of RHB-105 actives versus the comparator in the planned confirmatory Phase III study and a food-effect study with RHB-105. These PK studies are intended to support the planned confirmatory Phase III study with RHB-105, a proprietary, fixed-dose, oral combination therapy for the eradication of H. pylori infection. The two-arm, randomized, double-blind, active comparator confirmatory Phase III study, comparing RHB-105 against a dual therapy amoxicillin and omeprazole regimen at equivalent doses, is planned to be initiated by April of 2017, after completion of the ongoing supportive PK program and submission of clinical study reports to the FDA. The confirmatory Phase III study is planned to enroll approximately 440 patients in up to 55 clinical sites in the U.S. The planned confirmatory Phase III study, along with the results from the successfully completed first Phase III study with RHB-105 and data to be obtained from the ongoing supportive PK program, are expected to support a U.S. New Drug Application for RHB-105. 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 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 only 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. RHB-105 was granted Qualifying Infectious Disease Product designation by the 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, RHB-105 is entitled, its QIDP status, to receive 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 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, 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. 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%. Despite the strong unmet medical need, no new drug has been approved by the FDA for this indication in over a decade. The 2015 global and U.S. market potential for H. pylori eradication therapies at current 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.