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The positive results from the pharmacokinetic study support the continuation of the ERADICATE Hp study - a Phase III clinical study currently underway in the U.S., evaluating RHB-105 as a first-line therapy for H. pylori bacterial infection
The objectives of the PK study were to evaluate RHB-105's pharmacokinetics and bioavailability properties, and to assess safety
RedHill recently announced that the first patients have been dosed in the ERADICATE Hp Phase III study, with data expected by the third quarter of 2014
TEL-AVIV, Israel, Dec. 23, 2013 (GLOBE NEWSWIRE)
-- RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) (the "Company" or "RedHill"), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late stage, proprietary formulations and combinations of existing drugs, today reported positive results from a pharmacokinetic (PK) study with RHB-105, a proprietary combination therapy, oral capsule formulation, for eradication of
Helicobacter pylori (
H. pylori) infection, a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa associated lymphoid tissue (MALT) lymphoma.
The results of the PK study, 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 (CRO) which conducted the study. The final independent report from the CRO is expected in the coming weeks.
The objective of the randomized open-label, 2-arm crossover PK study was to evaluate 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 assess the safety of the RHB-105 combination formulation in healthy volunteers.
The positive results of the PK study provide support for the continuation of the RHB-105 ERADICATE Hp Phase III study that is currently underway in the U.S.