Redhill Biopharma Starts Confirmatory Phase 3 Study

Redhill Biopharma said Thursday it has started a confirmatory phase 3 study of RHB-105, now branded Talicia, for the treatment of H. pylori infection.

The study plans 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 assessed for the study’s primary endpoint of eradication of H. pylori infection at 42 through 70 days after initiation of treatment. Subject to a successful outcome and any additional regulatory feedback, the trial, along with the results from a prior phase 3 study, are expected to support a potential new drug application in the US.

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