RedHill Reports Positive PK Study Results With RHB-105 For H. Pylori Infection

(RTTNews) - RedHill Biopharma Ltd. (RDHL) announced positive results from a pharmacokinetic or PK study with RHB-105, a proprietary combination therapy, oral capsule formulation, for eradication of Helicobacter pylori or H. pylori infection, a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa associated lymphoid tissue or MALT lymphoma.

The PK results of the trial, including the pharmacokinetics, bioavailability and safety of RHB-105, are subject to final quality assurance and an independent study report by the Canadian clinical research organization, which conducted the study. The final independent report from the CRO is expected in the coming weeks.

The randomized open-label, 2-arm crossover PK trial's goal was to assess the pharmacokinetics and bioavailability of the RHB-105 all-in-one oral capsule and compare those to the concomitant administration of the three individual active drugs comprising RHB-105. The secondary objective of the PK study was to evaluate the safety of the RHB-105 combination formulation in healthy volunteers.

The positive PK study results provide support for the continuation of the RHB-105 ERADICATE Hp Phase III study that is currently underway in the U.S.

Recently, RedHill announced the dosing of the first patients in the Phase III ERADICATE Hp study, designed to evaluate the safety and efficacy of RHB-105 as a first-line treatment for confirmed H. pylori bacterial infection. Data from this Phase III study is likely to be available by the third quarter of 2014.

It is estimated that nearly two-thirds of the world's population is infected with H. pylori, and around 500,000 Americans suffer from peptic ulcer disease every year, which is caused by H. pylori bacterial infections.