Histopathology of H. pylori infection in a gastric foveolar pit demonstrated in endoscopic gastric biopsy. Credit: KGH.

RedHill Biopharma has completed patient enrolment in the Phase III ERADICATE Hp2 study of Talicia (RHB-105) in comparison with a dual therapy regimen of amoxicillin and omeprazole for the treatment of H. pylori infection.

The two-arm, randomised, double-blind, active comparator confirmatory trial has enrolled a total of 455 non-investigated dyspepsia patients with confirmed H. pylori infection at 55 clinical sites across the US.

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The patients were randomised in a 1:1 ratio to be given four capsules of either Talicia or the active comparator, three times a day for 14 days.

The primary endpoint of the trial is eradication of H. pylori infection at 43 through to 71 days after the beginning of treatment.

Top-line results from the trial are scheduled to be released later this year.

“Top-line results from the trial are scheduled to be released later this year.”

Depending upon the success of the trial and additional regulatory feedback, the ERADICATE Hp2 trial is expected to complete the package necessary for filing a New Drug Application (NDA) with the US Food and Drug Administration (FDA) for Talicia early next year.

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Talicia has already received the Qualified Infectious Disease Product (QIDP) designation from the FDA.

It is a fixed-dose oral combination therapy of two antibiotics and a proton pump inhibitor (PPI) in an oral capsule with a planned indication for the treatment of H. pylori infection, irrespective of ulcer status.

RedHill Biopharma noted that the first Phase III study of Talicia, titled ERADICATE Hp study, has successfully met its primary endpoint of superiority over historical standard-of-care (SoC) eradication rate of 70%.

H.pylori bacterial infection is a leading cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa-associated lymphoid tissue (MALT) lymphoma.

The infection is estimated to have affected more than half of the adult population across the globe.